chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 10-year-old male patient who received FLULAVAL TETRA (batch number JP3DA, expiry date 31st May 2018). Previously administered products included flu vaccine (received intranasal flu vaccine without any issue last year, but product name the patient could not recall). Concurrent medical conditions included reactive airways disease (prior to FLULAVAL administration). On 9th October 2017, the patient received FLULAVAL TETRA (intramuscular) .5 ml. In October 2017, less than a day after receiving FLULAVAL TETRA, the patient experienced extensive swelling of vaccinated limb, injection site erythema and skin warm. The patient was treated with MOTRIN, BENADRYL and prednisone. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and skin warm were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and skin warm to be almost certainly related to FLULAVAL TETRA. Additional information was provided as follows: On 9th October 2017, about 2:30 pm, the vaccine was administered by a medical assistant at the doctor's office on the left upper arm. Later that night, the patient went to bed without issue but woke with his left arm being swollen, red at the injection site, and feeling hot. On 11th October 2017, a day before the reporting, the patient was seen by the doctor. The doctor said this reaction must have started during the night while the patient was asleep. The way the patient's arm appeared reminded him of reactions typical for whole cellular DPT vaccines from many years ago in the past and that he had never seen this type of reaction after a influenza vaccine. The patient's left arm swelling started at the top of the patient's left shoulder and extended down his upper arm just a little past his elbow, with the site of injection being inside the area of redness. The patient's left arm symptoms seemed to not be resolving and getting worse. After the vaccine was administered the patient had been receiving MOTRIN and BENADRYL therapies. The patient was not bedridden. The patient's left arm was now in a sling which was the doctor said was a bit of problem because the patient was left-handed. The doctor granted permission to be contacted with further related questions, and the call was transferred to Medical Information team regarding his outstanding inquiry of whether or not this type of reaction could happen for this vaccine. In the morning of the reporting date, the reporter mentioned now considering possible Prednisone therapy for the patient.
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Skin warm
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 10-year-old male patient who received FLULAVAL TETRA (batch number JP3DA, expiry date 31st May 2018). Previously administered products included flu vaccine (received intranasal flu vaccine without any issue last year, but product name the patient could not recall). Concurrent medical conditions included reactive airways disease (prior to FLULAVAL administration). On 9th October 2017, the patient received FLULAVAL TETRA (intramuscular) .5 ml. In October 2017, less than a day after receiving FLULAVAL TETRA, the patient experienced extensive swelling of vaccinated limb, injection site erythema and skin warm. The patient was treated with MOTRIN, BENADRYL and prednisone. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and skin warm were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and skin warm to be almost certainly related to FLULAVAL TETRA. Additional information was provided as follows: On 9th October 2017, about 2:30 pm, the vaccine was administered by a medical assistant at the doctor's office on the left upper arm. Later that night, the patient went to bed without issue but woke with his left arm being swollen, red at the injection site, and feeling hot. On 11th October 2017, a day before the reporting, the patient was seen by the doctor. The doctor said this reaction must have started during the night while the patient was asleep. The way the patient's arm appeared reminded him of reactions typical for whole cellular DPT vaccines from many years ago in the past and that he had never seen this type of reaction after a influenza vaccine. The patient's left arm swelling started at the top of the patient's left shoulder and extended down his upper arm just a little past his elbow, with the site of injection being inside the area of redness. The patient's left arm symptoms seemed to not be resolving and getting worse. After the vaccine was administered the patient had been receiving MOTRIN and BENADRYL therapies. The patient was not bedridden. The patient's left arm was now in a sling which was the doctor said was a bit of problem because the patient was left-handed. The doctor granted permission to be contacted with further related questions, and the call was transferred to Medical Information team regarding his outstanding inquiry of whether or not this type of reaction could happen for this vaccine. In the morning of the reporting date, the reporter mentioned now considering possible Prednisone therapy for the patient.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immune system disorder, Influenza like illness, Nerve injury, Neurostimulator implantation, Pain
Clinical narrative: This spontaneous report was received from a 64 year old male consumer referring to himself. The patient had no medical history, drug reactions/allergies or concomitant medication. The patient's concurrent condition included flu. On 11-OCT-2014 the patient was vaccinated with one dose of ZOSTAVAX in his arm for prophylaxis (strength, route, dose, units or lot number were not reported). On approximately 18-OCT-2014, about a week after receiving ZOSTAVAX, the patient became violently ill. The patient stated that it "felt like the flu only worse" and he also felt electrical shocks going from his feet up to his face to the point of distorting his vision. The patient went to his then primary doctor (no demographics provided) who referred him to an unspecified neurologist. It was also reported that on an unknown date the patient went to an unspecified neurological clinic and during this time he underwent six months of "IPIG" treatments that had him receive an infusion of unspecified liquid every three weeks. On an unknown date the clinic diagnosed the patient with nerve damage and referred him to an unspecified pain physician. The patient was placed on therapy with LYRICA, morphine, and gabapentin for the pain. During the summer of 2017, the patient had an outpatient procedure at the hospital, to have a neurostimulator system (AXIUM) implanted, but the patient stated that he was still in pain after that. The outcome of the events was reported as not recovered. The causality assessment between the events and ZOSTAVAX was not reported. Upon internal review, nerve damage was determined to be medically significant.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a 64 year old male consumer referring to himself. The patient had no medical history, drug reactions/allergies or concomitant medication. The patient's concurrent condition included flu. On 11-OCT-2014 the patient was vaccinated with one dose of ZOSTAVAX in his arm for prophylaxis (strength, route, dose, units or lot number were not reported). On approximately 18-OCT-2014, about a week after receiving ZOSTAVAX, the patient became violently ill. The patient stated that it "felt like the flu only worse" and he also felt electrical shocks going from his feet up to his face to the point of distorting his vision. The patient went to his then primary doctor (no demographics provided) who referred him to an unspecified neurologist. It was also reported that on an unknown date the patient went to an unspecified neurological clinic and during this time he underwent six months of "IPIG" treatments that had him receive an infusion of unspecified liquid every three weeks. On an unknown date the clinic diagnosed the patient with nerve damage and referred him to an unspecified pain physician. The patient was placed on therapy with LYRICA, morphine, and gabapentin for the pain. During the summer of 2017, the patient had an outpatient procedure at the hospital, to have a neurostimulator system (AXIUM) implanted, but the patient stated that he was still in pain after that. The outcome of the events was reported as not recovered. The causality assessment between the events and ZOSTAVAX was not reported. Upon internal review, nerve damage was determined to be medically significant.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Influenza like illness, Malaise, Metamorphopsia, Nerve injury
Clinical narrative: This spontaneous report was received from a 64 year old male consumer referring to himself. The patient had no medical history, drug reactions/allergies or concomitant medication. The patient's concurrent condition included flu. On 11-OCT-2014 the patient was vaccinated with one dose of ZOSTAVAX in his arm for prophylaxis (strength, route, dose, units or lot number were not reported). On approximately 18-OCT-2014, about a week after receiving ZOSTAVAX, the patient became violently ill. The patient stated that it "felt like the flu only worse" and he also felt electrical shocks going from his feet up to his face to the point of distorting his vision. The patient went to his then primary doctor (no demographics provided) who referred him to an unspecified neurologist. It was also reported that on an unknown date the patient went to an unspecified neurological clinic and during this time he underwent six months of "IPIG" treatments that had him receive an infusion of unspecified liquid every three weeks. On an unknown date the clinic diagnosed the patient with nerve damage and referred him to an unspecified pain physician. The patient was placed on therapy with LYRICA, morphine, and gabapentin for the pain. During the summer of 2017, the patient had an outpatient procedure at the hospital, to have a neurostimulator system (AXIUM) implanted, but the patient stated that he was still in pain after that. The outcome of the events was reported as not recovered. The causality assessment between the events and ZOSTAVAX was not reported. Upon internal review, nerve damage was determined to be medically significant.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neurostimulator implantation, Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a 64 year old male consumer referring to himself. The patient had no medical history, drug reactions/allergies or concomitant medication. The patient's concurrent condition included flu. On 11-OCT-2014 the patient was vaccinated with one dose of ZOSTAVAX in his arm for prophylaxis (strength, route, dose, units or lot number were not reported). On approximately 18-OCT-2014, about a week after receiving ZOSTAVAX, the patient became violently ill. The patient stated that it "felt like the flu only worse" and he also felt electrical shocks going from his feet up to his face to the point of distorting his vision. The patient went to his then primary doctor (no demographics provided) who referred him to an unspecified neurologist. It was also reported that on an unknown date the patient went to an unspecified neurological clinic and during this time he underwent six months of "IPIG" treatments that had him receive an infusion of unspecified liquid every three weeks. On an unknown date the clinic diagnosed the patient with nerve damage and referred him to an unspecified pain physician. The patient was placed on therapy with LYRICA, morphine, and gabapentin for the pain. During the summer of 2017, the patient had an outpatient procedure at the hospital, to have a neurostimulator system (AXIUM) implanted, but the patient stated that he was still in pain after that. The outcome of the events was reported as not recovered. The causality assessment between the events and ZOSTAVAX was not reported. Upon internal review, nerve damage was determined to be medically significant.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (Lot R41774, Expiration Date Apr2018, NDC number 0005197101) at the age of 69 years, intramuscular in right arm on 11Oct2017 10:53 at 0.5 ml, single for immunisation. Medical history included osteoporosis and rheumatoid arthritis. Patient was taking other unspecified medications. The patient experienced itching and swelling around the area the vaccine was given on 17Oct2017. The patient reported that itching and swelling were around the injection site and it swelled up the size of a softball. The events were considered medically significant. The outcome of the events was not recovered. Sender's Comments: A causal association between administration of PREVNAR 13 and the events cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 69.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pruritus, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (Lot R41774, Expiration Date Apr2018, NDC number 0005197101) at the age of 69 years, intramuscular in right arm on 11Oct2017 10:53 at 0.5 ml, single for immunisation. Medical history included osteoporosis and rheumatoid arthritis. Patient was taking other unspecified medications. The patient experienced itching and swelling around the area the vaccine was given on 17Oct2017. The patient reported that itching and swelling were around the injection site and it swelled up the size of a softball. The events were considered medically significant. The outcome of the events was not recovered. Sender's Comments: A causal association between administration of PREVNAR 13 and the events cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 43.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Within 2-3 days of receiving the vaccine, I experienced numbness and tingling in my right arm. When it didn't go away after a day or two, I thought about what was different about that arm than the other arm. I tried to recall sleeping on it weird or carrying something out of the ordinary. And then I remembered the tetanus shot. That is the only thing I've ever come up with that was unusual. The numbness, but mostly the tingling sensation I am certain was a pinched nerve or whatever can make that feeling happen was quite intense for a while, in that I was aware of it here and there throughout the day. I got used to holding my arm in ways that wouldn't aggravate it, but I mostly got used to the sensation. After about six weeks, I would mostly experience it in the mornings or any time I rested/sagged my shoulders, and the feeling ebbed a bit most of the rest of the time--or I got used to it. I kept thinking it was getting better, and after about 3-4 months (it was quite gradual) it was okay again. I haven't suffered anything similar since that time. I should note that it was primarily my upper arm--occasionally the tingling may have gone a bit past my elbow, but mostly it was contained within my upper right arm.
Age: 1.33
Sex: F
Vaccine: PNC13
Symptoms: Abnormal faeces, Diarrhoea, Fall, Gait disturbance, Gait inability
Clinical narrative: 5 days after the vaccination patient exhibited right leg weakness. I had been carrying her all morning and when I set her down to walk she immediately fell forward. I picked her up and she attempted to walk and fell again. She appeared unable to use her right leg properly. I carried her a bit and set her down to walk again. She dragged her right leg and toes and tried to walk. Her leg appeared to give out or exhibit sudden weakness and she would fall. I drove 10 minutes and got her out of the car. She still exhibited leg weakness. She showed no signs of pain, just frustration. I took her to the ER. The leg weakness continued for about 3-4 hours from when I first observed it. She also had diarrhea and foul smelling stools since the vaccine. She also showed unusual irritability since the vaccine.
Age: 1.33
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Irritability, Muscular weakness, Stool analysis normal, X-ray of pelvis and hip normal
Clinical narrative: 5 days after the vaccination patient exhibited right leg weakness. I had been carrying her all morning and when I set her down to walk she immediately fell forward. I picked her up and she attempted to walk and fell again. She appeared unable to use her right leg properly. I carried her a bit and set her down to walk again. She dragged her right leg and toes and tried to walk. Her leg appeared to give out or exhibit sudden weakness and she would fall. I drove 10 minutes and got her out of the car. She still exhibited leg weakness. She showed no signs of pain, just frustration. I took her to the ER. The leg weakness continued for about 3-4 hours from when I first observed it. She also had diarrhea and foul smelling stools since the vaccine. She also showed unusual irritability since the vaccine.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: First few days just a little sore to be expected. Day 3 thru 5 pain continues to gain in intensity. Day 14 pain centrally located at injection site and has spread to lower part of the next and down to elbow. Pain is intense like a pulled mussel. Now head and neck movement also experience some pain when moved. Arm is constantly hurting,  even when sleeping and at rest. I have not got e in for any additional evaluation at this point thinking this would go away after a few days. Now two weeks it is not getting any better. I will be seeking some assistance from Eagle Family medicine soon if relief does not occur soon.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus generalised
Clinical narrative: Redness, swelling at site with induration. Reported itchiness over body. Denies any breathing difficulties. Seen in ED treated with Prednisone, BENADRYL and Ibuprofen and/or TYLENOL. Reports today much improved. Swelling down. Itchiness resolved. To start on prednisone dose tapering.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PT had left arm redness, swelling, and pain after receiving injections. Reported to pharmacist 5pm the next day. Pain was relieved by Aleve.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient's husband described pain in shoulder and inability to raise arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PT had left arm redness, swelling, and pain after receiving injections. Reported to pharmacist 5pm the next day. Pain was relieved by Aleve.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. The patients concurrent condition included psoriasis. In approximately July 2017 reported as 2 months ago, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and indication were not reported). Concomitant therapies included MERCK STERILE DILUENT. On an unknown date the patient experienced flare up of psoriasis that was unstable at the time of the report. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant reporting on a 15 month old patient of unknown gender. There was non information regarding the patient's concurrent conditions. The patient's concomitant medication included PREVNAR 13. The patient had no pertinent medical history. On 13-JUL-2017, the patient received an unspecified dose of M-M-R II (lot # reported as M098365; strength and expiration date were not reported) reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported), intramuscular (incorrect route of drug administration) for prophylaxis (anatomical location not reported). On the same date, the patient received an unspecified dose of VARIVAX for prophylaxis (strength, route of administration, lot number and expiration date were not reported). On 13-JUL-2017, the patient had an "immediate reaction"; the patient experienced local swelling, redness at site which increased into the next day. The patient was treated with BENADRYL as it was suggested by the medical assistant. No lab diagnostics/studies were performed. On an unspecified date in 2017, the patient recovered from the adverse events injection site erythema and local swelling; the reporter stated that the patient was doing fine. The reporter did not assess the causal relationship between the aforementioned events and therapy with M-M-R II, sterile diluent (manufacturer unknown) or VARIVAX. Lot number M098365 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 30-AUG-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (strength, frequency, lot# and expiration date were not provided) for prophylaxis. The doses of ZOSTAVAX were exposed to a temperature excursion of 6° Fahrenheit (°F) to 14°F (7.9°F) during a time frame of 3 hours and 45 minutes, which was not detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse, concerning a patient of an unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 29-SEP-2017, the patient was vaccinated with one unspecified expired dose of ZOSTAVAX strength: 19400 PFU subcutaneously, lot number: M014310 with expiration date of 26-MAY-2017 (dose number and anatomical location were not provided) for prophylaxis, reconstituted with sterile diluent (MRK) (lot number and expiration date were unknown). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' concurrent conditions, concomitant medications or medical history was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ that underwent a temperature excursion of 0° centigrade to 1° centigrade, during 4 hours, (lot # N014980 with an expiration date in 16-NOV-2018) orally, for prophylaxis. No adverse effects were reported. Data logger was involved. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 06-OCT-2017, the patient was vaccinated with improperly stored PNEUMOVAX 23 (first dose; exact dose and route of administration were not reported; lot # N011491 with the expiration date of 01-NOV-2018) for prophylaxis. The administered PNEUMOVAX 23 underwent a temperature excursion of 31 Fahrenheit degrees or colder (19.8F) for 12 hours. Digital data logger was involved to capture the temperature excursion. There were no previous temperature excursions captured. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 06-OCT-2017, the patient was vaccinated with ZOSTAVAX (exact dose and route of administration were not reported; lot # N020939 with the expiration date of 26-OCT-2018) reconstituted with sterile diluent (lot # N020611 with the expiration date of 04-NOV-2019) for prophylaxis. During the administration, an unspecified part of the ZOSTAVAX dose was not administered due to leakage on the patient's arm. No adverse effects were reported.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an elderly 68 year-old male patient with no pertinent medical history, concomitant medications or known drug reactions and allergies. On 28-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the right deltoid (exact dose, dose number were not reported; lot # M015418 with the expiration date of 12-OCT-2017) for prophylaxis. On 29-SEP-2017, the patient developed redness and swelling in his right arm. No treatment was given and the events resolved "on its own" on 01-OCT-2017. No lab diagnostic studies were performed. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Age: 62.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 17-AUG-2017, a 62 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX 23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008716: US-009507513-1710USA008717.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 11-AUG-2017, a 73 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX 23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008716: US-009507513-1710USA008717.
Age: 36.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 02-AUG-2017, a 36 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008716: US-009507513-1710USA008717.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 09-AUG-2017, a 74 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX 23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008715: US-009507513-1710USA008716: US-009507513-1710USA008717.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 22-AUG-2017, a 71 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX 23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008716: US-009507513-1710USA008717.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 03-AUG-2017, a 66 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008717.
Age: 88.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 11-AUG-2017, an 88 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008716.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-OCT-2017, the patient was vaccinated with 1 expired dose of M-M-R II subcutaneously, lot# L039551 and expiration date 07-OCT-2017, reconstituted with sterile diluent, lot#  L044727 and expiration date 01-JUN-2018. There were no adverse effects reported.
Age: 12.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring  to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA011654:
Age: 11.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-JUn-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Age: 83.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 83 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Age: 39.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 83 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Age: 38.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 38 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Age: 44.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 44 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Age: 23.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 23 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654
Age: 30.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 30 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Age: 59.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 59 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUN-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Joint range of motion decreased, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a consumer on 26-Sep-2017 and additional information received on 26-Sep-2017. This case involves a female patient (onset age not reported) who was vaccinated with a 0.5 ml single dose of ADACEL (batch number, expiry date was not reported) in left deltoid via intramuscular route on 28-Jul-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, in the evening same day after vaccination, the patient experienced tingling of the left hand. On an unknown date after the vaccination, the symptoms progressed to include a generalized weakness of the body, left hand was extremely painful and had limited ROM (range of motion) and her hand and arm swelled up. It was also reported that the symptoms had progressed over time. The patient's laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 26-Sep-2017 and additional information received on 26-Sep-2017. This case involves a female patient (onset age not reported) who was vaccinated with a 0.5 ml single dose of ADACEL (batch number, expiry date was not reported) in left deltoid via intramuscular route on 28-Jul-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, in the evening same day after vaccination, the patient experienced tingling of the left hand. On an unknown date after the vaccination, the symptoms progressed to include a generalized weakness of the body, left hand was extremely painful and had limited ROM (range of motion) and her hand and arm swelled up. It was also reported that the symptoms had progressed over time. The patient's laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Dysgeusia, Dysphonia, Erythema, Injection site erythema
Clinical narrative: Initial unsolicited case received from a nurse on 05 Oct 2017. This case is linked with the cases 2017SA199664 and 2017SA199663 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE MULTI DOSE VIALS (Batch number (reported as product 627-15), expiry date, dose, dose in series, route and site of administration were not reported) on 03 Oct 2017. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed metallic taste in mouth, followed by redness at injection site, progressing up arm to neck with hoarseness. It was reported as the patient required treatment in Emergency department. Relevant lab tests and corrective treatment was not reported. Outcome of all the events were not reported. List of documents held by sender: none.