chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lip swelling, Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of lip swelling in a male patient who received BEXSERO. Concomitant products included BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced lip swelling and welts. On an unknown date, the outcome of the lip swelling and welts were unknown. It was unknown if the reporter considered the lip swelling and welts to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain, redness and swelling at the injection site with the first dose of BEXSERO. This case was reported via vaccine inside sales representative at time of report of reaction to second dose. No lot number or expiration date or further details were reported. The physician was expected to call with a more detailed report. This case has been linked with case US2017109005 (same patient, reported for 1st dose of BEXSERO).
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported via vaccine inside sales representative at time of report of reaction to second dose. No lot number or expiration date or further details were reported. The physician was expected to call with a more detailed report. This case has been linked with case US2017109009, reported by the same patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Malaise, Neuralgia, Pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with no drug reactions or allergies. The patient's pertinent medical history included asplenia. On 09-NOV-2015, the patient was vaccinated once with a dose of ZOSTAVAX (lot number L028281, expiration date: 28-OCT-2016) dose 0.65 ml, subcutaneously to prevent shingles. There was no concomitant medication. On 10-NOV-2015, the patient was not feeling well and went to see her physician, who diagnosed her with internal shingles. The physician informed the patient that she ended up with internal shingles because of her preexisting disease - asplenia. The physician prescribed acyclovir 800 mg as a treatment for the patient. The outcome of the events was reported as recovered on an unknown date in November 2015. The relatedness between the events and ZOSTAVAX was not reported. The event of internal shingles was considered to be life threatening by the reporter because the doctor told the patient that if it was left untreated it could have gone to her brain. Follow up information has been received on 29-DEC-2015 that all telephone attempts to obtain follow up information had been unsuccessful. Follow up information was received from the patient on 30-SEP-2016. The patient reported that she had not recovered and was still experiencing nerve pain and throbbing in both arms and wrist (onset dates were unspecified). The patient was treated with gabapentin, naproxen, unspecified "patches", ibuprofen, acetaminophen (+) hydrocodone bitartrate (NORCO) (dosing regimen and frequency were unknown), all of which have not to date resolved the nerve pain. The patient had seen several doctors outside of her primary physician. No further symptoms were provided. There was no product quality complaint reported. The outcome of the events of nerve pain and throbbing in both arms and wrist was reported as not recovered at the time of the report. The reporter did not provide the causality assessment for the events. Follow-up information was received from a patient on 07-JUL-2017. The patient reported that on 07-NOV-2015 (earlier reported as 09-NOV-2015), the patient was vaccinated with a dose of ZOSTAVAX by an unspecified pharmacist. The patient experienced shingles on an unspecified date(s)(earlier reported as 10-NOV-2015) and for an unspecified reason(earlier reported as because of her preexisting disease  asplenia). No further information available. Additional information has been requested. Product tab, event onset date and narrative updated.; Sender's Comments: , MERCK 1511USA013112:Mfr number.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with no drug reactions or allergies. The patient's pertinent medical history included asplenia. On 09-NOV-2015, the patient was vaccinated once with a dose of ZOSTAVAX (lot number L028281, expiration date: 28-OCT-2016) dose 0.65 ml, subcutaneously to prevent shingles. There was no concomitant medication. On 10-NOV-2015, the patient was not feeling well and went to see her physician, who diagnosed her with internal shingles. The physician informed the patient that she ended up with internal shingles because of her preexisting disease - asplenia. The physician prescribed acyclovir 800 mg as a treatment for the patient. The outcome of the events was reported as recovered on an unknown date in November 2015. The relatedness between the events and ZOSTAVAX was not reported. The event of internal shingles was considered to be life threatening by the reporter because the doctor told the patient that if it was left untreated it could have gone to her brain. Follow up information has been received on 29-DEC-2015 that all telephone attempts to obtain follow up information had been unsuccessful. Follow up information was received from the patient on 30-SEP-2016. The patient reported that she had not recovered and was still experiencing nerve pain and throbbing in both arms and wrist (onset dates were unspecified). The patient was treated with gabapentin, naproxen, unspecified "patches", ibuprofen, acetaminophen (+) hydrocodone bitartrate (NORCO) (dosing regimen and frequency were unknown), all of which have not to date resolved the nerve pain. The patient had seen several doctors outside of her primary physician. No further symptoms were provided. There was no product quality complaint reported. The outcome of the events of nerve pain and throbbing in both arms and wrist was reported as not recovered at the time of the report. The reporter did not provide the causality assessment for the events. Follow-up information was received from a patient on 07-JUL-2017. The patient reported that on 07-NOV-2015 (earlier reported as 09-NOV-2015), the patient was vaccinated with a dose of ZOSTAVAX by an unspecified pharmacist. The patient experienced shingles on an unspecified date(s)(earlier reported as 10-NOV-2015) and for an unspecified reason(earlier reported as because of her preexisting disease  asplenia). No further information available. Additional information has been requested. Product tab, event onset date and narrative updated.; Sender's Comments: , MERCK 1511USA013112:Mfr number.
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse referring to an 11 year old male patient. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 26-APR-2017, the patient was vaccinated with the second dose of GARDASIL 9 0.5 ml, intramuscularly, in the left arm, for prophylaxis (frequency, lot number and expiration date were not provided). On an unspecified date in 2017, the patient developed a hard lump at the injection site on his left arm. Furthermore, it was also reported that the patient sought medical attention and an unspecified treatment was prescribed for the event. No product quality complaint (PQC) was involved.  At the time of reporting, the outcome of vaccination site mass was reported as not recovered, as a result, it was also reported that the patient would have a sonogram. The causal relationship between GARDASIL 9 and vaccination site mass was not provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This spontaneous report as received from a nurse referring to an 11 year old male patient. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 26-APR-2017, the patient was vaccinated with the second dose of GARDASIL 9 0.5 ml, intramuscularly, in the left arm, for prophylaxis (frequency, lot number and expiration date were not provided). On an unspecified date in 2017, the patient developed a hard lump at the injection site on his left arm. Furthermore, it was also reported that the patient sought medical attention and an unspecified treatment was prescribed for the event. No product quality complaint (PQC) was involved.  At the time of reporting, the outcome of vaccination site mass was reported as not recovered, as a result, it was also reported that the patient would have a sonogram. The causal relationship between GARDASIL 9 and vaccination site mass was not provided. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Ultrasound scan
Clinical narrative: Intussusception.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Left arm became red and feverish approximately 8 hours after pt was vaccinated on 7/17/17.  A 3" bruise developed across her arm. Reaction is still feverish to the touch on 7/20/17. Pt was instructed to use a cold compress on her arm in addition to taking her current medications.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: Inguinal lymphadenopathy - both sides, swollen, 1/2 diameter fever - 101-104 degrees F.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle tightness, Oropharyngeal pain, Pain in jaw, Trismus
Clinical narrative: Mom called 7/20/17 at 730 am and stated sons jaw was "tight", "locked" and painful. Did complain of sore throat when swallows.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Abnormal behaviour, Dry skin, Haemorrhage, Listless, Pyrexia
Clinical narrative: Immediately following vaccination my daughter became not herself she was listless and had a high fever. She woke up from her nap covered from head to toe in hives. Her skin went from being smooth baby skin to dry as sandpaper and broken and bleeding constantly she suffered from this skin condition in its severity for over 6 months. I took her back to her pediatric doctor who couldn't find a cure for it also to a dermatologist and at one time we had an emergency room visit. She still is troubled by these hives as has not completely healed.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Skin fissures, Urticaria
Clinical narrative: Immediately following vaccination my daughter became not herself she was listless and had a high fever. She woke up from her nap covered from head to toe in hives. Her skin went from being smooth baby skin to dry as sandpaper and broken and bleeding constantly she suffered from this skin condition in its severity for over 6 months. I took her back to her pediatric doctor who couldn't find a cure for it also to a dermatologist and at one time we had an emergency room visit. She still is troubled by these hives as has not completely healed.
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from an office manager refers to a 57 year old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies were provided. On 30-JUN-2017, the patient was vaccinated with pediatric RECOMBIVAX HB 5/0.5 mcg/ml for prophylaxis (dose, route, indication, lot number and expiration date were not reported) due to a human error. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA006672.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Fatigue, Local swelling, Nuclear magnetic resonance imaging normal, Rash
Clinical narrative: This spontaneous report was received from the patient's husband referring to his wife, a 29 year old non-pregnant female patient. The patient had not any pertinent medical history, concurrent condition nor had been taking any concomitant medication. On 19-JUN-2017, reported as approximately "3 weeks ago on Monday", the patient was vaccinated with one dose of PNEUMOVAX23 subcutaneously for pneumonia prevention (strength, Lot # and expiration date were not reported). On unspecified day in June 2017, reported as "2 or 3 days" after his wife vaccine administration, the patient began to develop symptoms that started off as a rash on the back of her neck and shoulders and then the rash progressed down to her arms and chest area. Then, the husband said his wife's rash proceeded to get worse and she developed sores in the rash which got infected. Also, since an unknown day in June 2017, reported as since getting the vaccine, the patient had been feeling some fatigue. On 10-JUL-2017, the patient went back to see the physician, who administered the vaccine, for a follow-up visit because her symptoms were not getting any better but the physician did not think these symptoms were related to PNEUMOVAX 23 and the doctor prescribed her an unspecified topical cream to help treat the infection. On 11-JUL-2017, at morning, when the patient woke up, her face was slightly swollen. The following morning, on 12-JUL-2017, again when the patient woke up, her face was really swollen and also the sides of her neck were swollen and on the back of her neck a baseball size area had become swollen, raised up and that baseball size patch also felt hot to the touch as if a fever had developed. After this, on this same date at morning, the husband took his wife to the emergency room. Over there, some blood work was ran and a Magnetic Resonance Imaging (MRI) was performed and all test results came back to normal. Here, a prednisone shot was given and the patient was released with no hospitalization occurred. At the reporting time, the patient was not recovered from the events. The patient's husband did not provide the causality assessment between the events (local swelling, fatigue, rash, skin lesion, dermatitis infected, pyrexia and swelling face) and vaccination with PNEUMOVAX 23. Upon internal review, local swelling, swelling face and pyrexia were considered as a medically significant events as they were treated in ER with prednisone.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Skin infection, Skin ulcer, Skin warm, Swelling face
Clinical narrative: This spontaneous report was received from the patient's husband referring to his wife, a 29 year old non-pregnant female patient. The patient had not any pertinent medical history, concurrent condition nor had been taking any concomitant medication. On 19-JUN-2017, reported as approximately "3 weeks ago on Monday", the patient was vaccinated with one dose of PNEUMOVAX23 subcutaneously for pneumonia prevention (strength, Lot # and expiration date were not reported). On unspecified day in June 2017, reported as "2 or 3 days" after his wife vaccine administration, the patient began to develop symptoms that started off as a rash on the back of her neck and shoulders and then the rash progressed down to her arms and chest area. Then, the husband said his wife's rash proceeded to get worse and she developed sores in the rash which got infected. Also, since an unknown day in June 2017, reported as since getting the vaccine, the patient had been feeling some fatigue. On 10-JUL-2017, the patient went back to see the physician, who administered the vaccine, for a follow-up visit because her symptoms were not getting any better but the physician did not think these symptoms were related to PNEUMOVAX 23 and the doctor prescribed her an unspecified topical cream to help treat the infection. On 11-JUL-2017, at morning, when the patient woke up, her face was slightly swollen. The following morning, on 12-JUL-2017, again when the patient woke up, her face was really swollen and also the sides of her neck were swollen and on the back of her neck a baseball size area had become swollen, raised up and that baseball size patch also felt hot to the touch as if a fever had developed. After this, on this same date at morning, the husband took his wife to the emergency room. Over there, some blood work was ran and a Magnetic Resonance Imaging (MRI) was performed and all test results came back to normal. Here, a prednisone shot was given and the patient was released with no hospitalization occurred. At the reporting time, the patient was not recovered from the events. The patient's husband did not provide the causality assessment between the events (local swelling, fatigue, rash, skin lesion, dermatitis infected, pyrexia and swelling face) and vaccination with PNEUMOVAX 23. Upon internal review, local swelling, swelling face and pyrexia were considered as a medically significant events as they were treated in ER with prednisone.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (reported as an administrator), and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. On 11-JUL-2017, the patient was inadvertently administered a dose of VARIVAX lot # L025207, for prophylaxis (dose, frequency, and route were not reported) which expired on 07-JUL-2017. Other suspect therapies included sterile diluent (strength, dose, frequency, route, lot #, expiration date and indication were not reported). No adverse effects were reported.
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from an office manager refers to a 57 year old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies were provided. On 30-JUN-2017, the patient was vaccinated with pediatric RECOMBIVAX HB 5/0.5 mcg/ml for prophylaxis (dose, route, indication, lot number and expiration date were not reported) due to a human error. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA005560.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VAQTA (lot # N005274 with expiration date 03-APR-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006507: US-009507513-1707USA006676.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot # M003659 with expiration date 20-SEP-2017) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006507: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Rash on both thighs around injection sites.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Following two observations was noticed 1. At the site of the injection, the area became red, swollen, warm and itchy - this was noticed on the 11th day after the injection was administered. Area of erythema and swelling is approx. 1.5 x 2 inches 2. On her left upper arm on the inside just above the breast area a new lesion on a base of erythema 2 x1.5 inches with a 4mm lesion consistent with a varicella lesion - this to was noticed on the 11th day after injection 3. General fatigue and body pain was also noticed.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: Pain, Varicella post vaccine
Clinical narrative: Following two observations was noticed 1. At the site of the injection, the area became red, swollen, warm and itchy - this was noticed on the 11th day after the injection was administered. Area of erythema and swelling is approx. 1.5 x 2 inches 2. On her left upper arm on the inside just above the breast area a new lesion on a base of erythema 2 x1.5 inches with a 4mm lesion consistent with a varicella lesion - this to was noticed on the 11th day after injection 3. General fatigue and body pain was also noticed.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Left arm pain and muscle weakness. Started on September 26, 2016 and persisted until current date. Slight swelling in the left deltoid. Pain when lifting things or moving arm too far forwards or backwards. Simple tasks such as putting on a jacket or buckling a seatbelt were very painful. At time it was hard or impossible to lift bags or anything heavier than a few pounds. Went to doctor initially on 12/19/2016 and was given prednisone 10mg 6 day taper as well as baclofen. Returned to doctor on 12/30/2016 due to no progress after stopping prednisone. Prednisone helped while on it but the last few days of the taper pack the pain returned. On 12/30/2016 x-rays were done but came up negative. Tramadol was prescribed but did not help with pain, was referred to an orthopedist at this time. An appointment was made for January with the orthopedist but a snow day caused offices to close and appointments to be rescheduled. An appointment was made for May 11th at clinic with Dr. A cortisone shot was given as well as physical therapy exercises. The cortisone shot helped a little bit but pain continued on. Asked Pharmacy how to proceed and was referred to the CDC.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Heart rate increased, Hypotension, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in the shoulder and difficulty moving the arm where shot was given. Chills and fever of 102.6, low blood pressure, fast heartbeat.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Severe pain in the shoulder and difficulty moving the arm where shot was given. Chills and fever of 102.6, low blood pressure, fast heartbeat.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: SHE WAS EXPERIENCING NAUSEA VOMITING, PASSED OUT LATER CALLED EMS AND THEY TOOK HER TO ER.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a licensed practical nurse. The nurse stated that the name of PROQUAD sounded too similar to the name of QUADRACEL (manufacturer unspecified) and as a result, she placed her PROQUAD into the refrigerator, on an unknown date reported as "10 days ago", approximately on 13-JUN-2017.. The nurse did not report any labeling confusion for PROQUAD. No information about the diluent was provided. The PROQUAD was never administered to anyone. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician assistant refers to a adult patient of unknown age and gender. The patient concurrent condition, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # N003997 for prophylaxis. The temperature was reported as 9 degree Celsius to 25 degree Celsius (10 Celsius). The time frame was reported as 72 hours. No previous temperature excursion was noted. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a patient of unknown age and gender. The patient concurrent condition, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date after 3 to 4 weeks of receiving ZOSTAVAX, the patient experienced shingles. The outcome of herpes zoster was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 17-JUL-2017 from a registered nurse who reported that on unspecified dates, an unspecified amount of patients (age and gender not reported) received an improperly stored dose of VARIVAX (lot# M046924, expiration 28-NOV-2018) reconstituted with properly stored sterile water diluent (lot#/expiration unknown). Temperature/time frame was 6 degrees F to 14 degrees F for 18 minutes; 15 degrees F to 46 degrees F for 72 hours. There was no previous temperature excursion. No adverse effects reported. No additional information provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 03-JUL-2017 from a medical assistant. concerning a male patient of unknown age. No medical history or concomitant medications were reported. On 03-JUL-2017, the patient received a dose of PROQUAD (Lot # N013865, expires 31-OCT-2018) that was improperly stored and properly stored sterile diluent (N001543, expires 30-JUL-2019). No adverse effects reported. The vaccine PROQUAD (lot N013865, expires 31-OCT-2018) was at a temperature range of 15 degrees F  to 46 degrees F for 4 hours via a data logger. No previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a immunization official refers to multiple patients of unknown age and gender. No information regarding the patients pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown dates, multiple patients were vaccinated with improperly stored doses of PROQUAD lot # M044022, expiration 01-MAY-2018; VARIVAX Lot #M045204, exp 11-NOV-2018 and M034583 exp 27-JUL-2018; and ZOSTAVAX lot# M042504, exp 30-NOV-2017. Properly stored Sterile diluent lot# not reported. No adverse events were reported. Temperature 1-4 degrees Celsius to -10 degrees Celsius for 2 hours. Previous temperature excursion PROQUAD -14 degrees Celsius to -10 degrees Celsius for 1 hour and 30 minutes; VARIVAX -14 degrees Celsius to -10 for 15 hours and 30 minutes and ZOSTAVAX -14 degrees Celsius to -10 for 15 hours and 30 minutes A digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from nurse refers to an unspecified patient of unknown age. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unspecified date, the patient might have received an improperly stored dose of one of the following vaccines for prophylaxis, but he was unsure which of the vaccines the unspecified patient received. Names of the vaccines involved: GARDASIL 9 (N004799, expiry: 15-NOV-2019) or PNEUMOVAX 23 (M047519, expiry: 04-AUG-2018). The vaccines were exposed to temperature of 14 degree Fahrenheit for 7 hours. No adverse effects reported. The temperature excursion was detected by digital data logger. The vaccines had no previous temperature excursion. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received on 17-JUL-2017 from a consumer reporting on herself as a 63 year old female patient with penicillin allergy. The patient's medical history included sleep disorder and sciatica pain. On 12-JUL-2017 (also reported as 13-JUL-2017) the patient was vaccinated with ZOSTAVAX lot # M040146, expiration 26-DEC-2017, subcutaneous in the left arm for prophylaxis to prevent shingles.    Concomitant therapies included metformin, duloxetine hydrochloride, naproxen (reported as "nexproxin") and "levitroinin." The patient stated that about 4 hours after she received the ZOSTAVAX vaccine she was "incapacitated" and slept for 3 ½ hours. After she woke up she had pain going up her neck, "like meningitis." The pain, she said then traveled behind her ears and she had a severe headache. The patient reported she has a walnut size bump on her left arm injection site, along with skin blotches, and itchiness at the site. The outcome of "incapacitated", slept for 3 ½ hours, pain going up her neck, "like meningitis," pain, she traveled behind her ears, severe headache, and a walnut size bump on her left arm injection site, along with skin blotches, and itchiness at the site was unknown. The causality was not reported. Information has also been received on 17-JUL-2017 from a pharmacist. The pharmacist clarified that the date of ZOSTAVAX administration was on 12-JUL-2017. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Meningism, Neck pain, Rash macular
Clinical narrative: Information has been received on 17-JUL-2017 from a consumer reporting on herself as a 63 year old female patient with penicillin allergy. The patient's medical history included sleep disorder and sciatica pain. On 12-JUL-2017 (also reported as 13-JUL-2017) the patient was vaccinated with ZOSTAVAX lot # M040146, expiration 26-DEC-2017, subcutaneous in the left arm for prophylaxis to prevent shingles.    Concomitant therapies included metformin, duloxetine hydrochloride, naproxen (reported as "nexproxin") and "levitroinin." The patient stated that about 4 hours after she received the ZOSTAVAX vaccine she was "incapacitated" and slept for 3 ½ hours. After she woke up she had pain going up her neck, "like meningitis." The pain, she said then traveled behind her ears and she had a severe headache. The patient reported she has a walnut size bump on her left arm injection site, along with skin blotches, and itchiness at the site. The outcome of "incapacitated", slept for 3 ½ hours, pain going up her neck, "like meningitis," pain, she traveled behind her ears, severe headache, and a walnut size bump on her left arm injection site, along with skin blotches, and itchiness at the site was unknown. The causality was not reported. Information has also been received on 17-JUL-2017 from a pharmacist. The pharmacist clarified that the date of ZOSTAVAX administration was on 12-JUL-2017. No additional information was provided. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JUL-2017, the patient was vaccinated with the adult dose of VAQTA lot number N005605 with expiration date on 08-APR-2018, 1 ml (strength, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No further information was provided.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 24 year old female patient with allergy to BACTRIM. No information regarding the patient's pertinent medical history. On an unknown date (reported as late February 2017), the patient was vaccinated with second dose of GARDASIL 9 (route, dosage, lot number and expiration date not reported), for HPV preventation. Concomitant therapies included LEXAPRO, hormonal contraceptives (unspecified), and XANAX. On an unknown date, the patient experienced "strong abdominal pain and cramps" that lasted for hours after receiving the second dose of GARDASIL 9. The patient stated she had no reaction after receiving her first dose of GARDASIL 9. The outcome of abdominal pain was reported as recovered/resolved. No contact information available. Additional information is not expected.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot # M037770 with expiry: 01-JUN-2019. No adverse effects reported. The vaccine was exposed to a temperature of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007096: US-009507513-1707USA007097.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot # M037770 with expiry: 01-JUN-2019. No adverse effects reported. The vaccine was exposed to a temperature of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007096: US-009507513-1707USA007097.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare assistant (HCA) (also reported as administrator) concerning unspecified number of patients of unknown age and gender. Between 09-MAY-2017 to 13-JUL-2017, unspecified number of patients were vaccinated with improperly stored doses of VARIVAX lot # M047661 with expiry date: 02-DEC-2018 (dosing details, route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 9 hours. Data Logger was involved. No adverse effects were reported. There were no previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 12-JUL-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, lot # L035506 with expiry: 16-DEC-2016, for prophylaxis and sterile diluent (MRK INJ) (lot# and expiry unknown by the reporter). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 11-JUL-2017 and 12-JUL-2017, unspecified number of patients were vaccinated with improperly stored doses of VARIVAX lot# N002204 with expiry date: 19-JAN-2019 (dosing details, route were unknown) for prophylaxis together with sterile diluent (MERCK) (dose, frequency, lot #, expiry date and indication were not reported). It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 1 hour. Data Logger was involved. No adverse effects were reported. There were no previous temperature excursions. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report received from a physician referred to a 57 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAY-2017, the patient was vaccinated with PNEUMOVAX 23 in her right deltoid intramuscularly (lot: N010105, expiry date not reported). She called complaining of arm pain and then called on 25-MAY-2017 stating her arm was now immobile and she was still sore from the shot. She was given DEPO-MEDROL shot along with kewalo (as reported). A couple of days later, the patient was better. At the time of this report, patient recovered from the events. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patient of unknown age. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of one of the following lots of VARIVAX, but she was not sure the unspecified patient received from which lot. The various lot#s involved (N000681, expiry: 06-JAN-2019) (N012134, expiry: 17-APR-2019), (M048200, expiry: 07-DEC-2018) (M046005, expiry: 05-NOV-2018 (also reported as "18-NOV-2018") (M040138, expiry: 28-SEP-2018) (dosing details not provided), for prophylaxis. No adverse effects were reported. The vaccine lots were exposed to temperature in the range -9 degree Celsius to 8 degree Celsius for 1 hour and 45 minutes. Temperature excursion was detected by digital data logger. No previous temperature excursion occurred. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006789.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 20-JUN-2017, an adult patient was given pediatric dose of RECOMBIVAX HB lot # M010671, expiry date: 02-JUN-2018 (dosing details unknown) intramuscularly for prophylaxis. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect route of drug administration, Malaise
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender reporting on themself as a part of market research entitled "Zostavax Competitive Profile". On an unknown date, the patient was vaccinated with the first dose of VAQTA intravenously for Hepatitis A prophylaxis (lot # and expiration date were not reported). It was reported that the patient had a bad reaction to VAQTA and they got sick. Due to the event, the patient did not go back for the second shot, action taken was interrupted. It was reported that "this would be the same if they got sick after the first shot". The outcome of the event was not reported, however, it was reported that the event diminished after stopping the suspected therapy.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient "in her sixties". On an unknown date,  the patient was vaccinated with one dose of ZOSTAVAX (lot#, expiry date, dose and route of administration unknown) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT)(lot#, expiry date, dose and route of administration unknown). On an unknown date, sometime after the patient was vaccinated, she experienced shingles rash. She went to an urgent care facility on an unspecified date for treatment. The pharmacist was unaware if any treatment was provided to the patient at urgent care facility, and the patient had not presented back at pharmacy in which she received ZOSTAVAX since the date of administration. The outcome of shingles rash was unknown. Causality was not provided.      Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding an 84 year old male patient. Pertinent medical history was reported as none. Patient had drug reactions/allergies to sulfa. On 11-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, lot# M038216, expiry date: 31-JUL-2018, intramuscular for prophylaxis. Concomitant medications included blood pressure medicine, loratadine, pantoprazole, iron supplements and antibiotics in the past. On 11-JUL-2017, after few hours of vaccination, the patient experienced swelling in the bicep are in the arm in which injection was given. No treatment was given for the event. The patient sought medical attention by visiting the pharmacy. Outcome of the event was reported as not recovered. Causality of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and concomitant medication. On an unknown date in June 2017, the patient was vaccinated with ROTATEQ lot no- M044030/ expiration date-13-JUN-2018 for prophylaxis which had temperature excursion (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature/ time frame was 92 degree Fahrenheit-35 degree Fahrenheit for 168 hours. There was no previous temperature excursion and call was not because of digital data logger. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of GARDASIL 9 that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis. No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 mins. Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA006923: US-009507513-1707USA006921: US-009507513-1707USA006922.
Sex: U
Vaccine: PPV
Symptoms: Injection site infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # N003997, expiry date unknown) for an unknown indication. No concomitant medications were reported.  On an unknown date the patient experienced an infection at the injection site. The action taken and outcome of the event was unknown. The relatedness of the event to the therapy with PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M024678 for prophylaxis. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. Concurrent conditions, medical history and concomitant medication were not reported. On 10-JUL-2017, the patient was vaccinated with an incomplete dose of GARDASIL 9 (Lot # reported as "M07770" expiration date 01-JUN-2019) (Dose, route and anatomical location were not provided) for prophylaxis. A dose was drawn up from a GARDASIL 9 vial, but needle was not attached to syringe tightly. Consequently, some of GARDASIL 9 leaked out and trickled down on patient's arm. The nurse was not sure how much of GARDASIL 9 dose the patient actually received. No adverse effects reported.