chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer referring to her husband, a male patient of unknown age. The patient's concurrent conditions, concomitant medications and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (concentration, dose, frequency and anatomical place of vaccination were not reported), for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient developed shingles (herpes zoster). At the time of the reporting, the outcome of herpes zoster was unknown and the reporter did not provide a causality assessment between ZOSTAVAX and herpes zoster. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003161: US-009507513-1709USA004175.
Age: 34.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse, referring to a 34 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications and medical history were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA lot # N005274 for prophylaxis. No adverse effects were reported and no product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017,  these patients were administered improperly stored VAQTA (lot# N012324 with expiration date 05-APR-2018, lot# N005274 with expiration date 03-APR-2018, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004623: US-009507513-1709USA004621: US-009507513-1709USA004622: US-009507513-1708USA007735: US-009507513-1709USA004620.
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 multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017, these patients were administered improperly stored PNEUMOVAX 23 (lot# N014188 with expiration date 22-JAN-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004623: US-009507513-1709USA004621: US-009507513-1709USA004622: US-009507513-1709USA004619: US-009507513-1708USA007735.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017, these patients were administered improperly stored RECOMBIVAX HB (lot# M028322 with expiration date 31-MAY-2019, lot# M041384 with expiration date 07-JUL-2019, lot# N005996 with expiration date 07-JUL-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004623: US-009507513-1708USA007735: US-009507513-1709USA004622: US-009507513-1709USA004619: US-009507513-1709USA004620.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 07-JUL-2017, these patients were administered improperly stored ROTATEQ (lot# M034799 with expiration date 01-FEB-2018, lot# N000172 with expiration date 10-JUN-2018, lot# M043838 with expiration date 18-JUN-2018, lot# M046008 with expiration date 29-JUN-2018, oral, dose not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004623: US-009507513-1709USA004621: US-009507513-1708USA007735: US-009507513-1709USA004619: US-009507513-1709USA004620.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017, these patients were administered improperly stored PEDVAXHIB (lot# reported as N002913 with expiration date 23-FEB-2019, lot# reported as N003702 with expiration date 08-NOV-2019, lot# reported as N009802 with expiration date 19-DEC-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007735: US-009507513-1709USA004621: US-009507513-1709USA004622: US-009507513-1709USA004619: US-009507513-1709USA004620.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of M-M-R II (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004629: US-009507513-1708USA008490.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of ROTATEQ (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004629.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of GARDASIL (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004629:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004629.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of VAQTA (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004628: US-009507513-1709USA004629.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of VARIVAX (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004627: US-009507513-1709USA004629.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information about the patient´s medical history, concurrent conditions and concomitant medications was provided. On 06-SEP-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB, intramuscular for prophylaxis. No adverse effects were reported and no product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (lot# N012616 with expiration date 18-OCT-2018 or lot# N008826 with expiration date 12-SEP-2018 or lot# N004631 with expiration date 07-AUG-2018; concentration, dose, frequency and route were unknown) for prophylaxis; all reconstituted with properly stored sterile diluent (MRK) (lot# M047663 with expiration date 28-JUL-2019). The vaccines were stored at 6 to 14 degrees Fahrenheit for 45 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved in this case. This is one of two reports received from the same reporter. Lot number N012616 has been verified to be a valid lot number for PROQUAD. Sender's Comments: US-009507513-1708USA010302.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates between 31-MAY-2017 and 21-JUN-2017, these patients were administered improperly stored PEDVAXHIB (lot# L035878 with expiration date 11-AUG-2018, lot# L004738 with expiration date 10-NOV-2017, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 34 Fahrenheit (F) for 90 minutes and 49 Fahrenheit (F) for 30 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005365: US-009507513-1708USA010784.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates between 31-MAY-2017 and 21-JUN-2017, these patients were administered improperly stored GARDASIL 9 (lot# M024261 with expiration date 30-JUL-2018, lot# M035486 with expiration date 05-JUN-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 34 Fahrenheit (F) for 90 minutes and 49 Fahrenheit (F) for 30 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010784: US-009507513-1709USA005364.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown demographics. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored doses of VARIVAX (lot# M036292, expiry date 17-AUG-2018; lot# M041079, expiry date 06-OCT-2018; lot# M003440, expiry date 20-JAN-2018; lot# M049125, expiry date 15-DEC-2018; dose and route of administration not reported) for prophylaxis. The doses of vaccine underwent a temperature excursion of -14 degrees Celsius for 7 months. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004810.
Sex: M
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of seizure in a 19-year-old male patient who received BEXSERO. Previously administered products included MENACTRA. Concurrent medical conditions included cerebral palsy. On 30th August 2017, the patient received the 1st dose of BEXSERO .5 ml. On 30th August 2017, less than a day after receiving BEXSERO, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to BEXSERO. Additional details were provided as follows: The patient previously received all of his vaccines, including his MENACTRA. The age at vaccination was not reported. On 30th August 2017, in the late evening, the patient had a seizure. The patient was hospitalized for a few days and was released on Saturday or Sunday (the one just before the date of reporting) and everything appeared to be fine.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site bruising, Injection site induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: I got the anthrax shot in my Left arm at 9am on 9/9/2017 and by 4pm on the same day I noticed my arm had began to itch. The next day my arm had begun to swell and was hot to the touch. Also the area in which was the injection site was hard or stiff and bruised.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site reaction, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Macular rash starting on trunk that spread to entire body. Confluent around the injection site on the R thigh. Fever up to 103 started the day after vaccine given.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Soreness in upper arm and radiates to shoulder and back. Worse at night when trying to sleep on either side.
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Diet noncompliance
Clinical narrative: This serious initial spontaneous case, was received on 05-Sep-2017, from other non-health professional, concerning 91-year-old, elderly, male patient. The patient's historical conditions included prostate cancer which occurred and recovered on an unspecified date. The patient had taken flu vaccine previously, due to which he had diarrhoea. The patient's current conditions included glaucoma, high blood pressure and acid reflux since an unspecified date. Patient's breasts were cut off on an unspecified date. Concomitant medications included unspecified medications (reported as 4) for glaucoma and high blood pressure and NEXIUM for acid reflux. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, batch number, anatomical location, manufacturer and expiry date: not reported). It was reported that, on an unspecified date, the patient had diarrhoea from the flu shot and it was very severe over the years which lasted for a year. The patient was administered with an unspecified antibiotic before and after the flu shot. The patient stated that, there was no way to cure from the regular diarrhoea pills. He added that he cannot be on a diet. On an unspecified date, the patient was treated with unspecified antibiotics and CIPRO pills for the event. On an unspecified date, the patient had recovered from the event diarrhoea. The reporter assessed the event as non-serious.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Irritability, Myalgia, Pain
Clinical narrative: Injection of PNEUMOVAX. Soreness for three days and counting, extreme fatigue, irritability, muscle aches.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Mass, Swelling, Tenderness
Clinical narrative: So far not serious but I had a tetanus shot Friday in my right hip/buttocks and this morning (Sunday) I woke up with a small swollen lump in my right groin area. It is very tender to the touch and visibly swollen. After googling, this side effect showed up as incidents unknown so I thought I'd report it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The area of the injection was slightly warm and swelled mildly with an itching sensation for about an hour.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: It started off with aching joints and fever on the evening of the 10th. Treatment of this event was rest in bed till the next morning. The morning of the 11th aching joints went away but the site of the injection was swollen, hot to the touch, and sore. No treatment was done and still no treatment.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 25-AUG-2017 from a student regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently given a dose of ROTATEQ (dose and lot number not reported) sooner than recommended in the prescribing information. No adverse effects were reported. No other information was provided. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown demographics. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored doses of PROQUAD lot # N016993, expiry date 29-NOV-2018 (albumin status: recombinant human albumin, dose and route of administration not reported) for prophylaxis. The doses of vaccine underwent a temperature excursion of -14 degrees Celsius for 7 months. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA005518.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored doses of VARIVAX (lot# N017698, expiry date 09-JUN-2019; lot# M038856, 14-SEP-2018, expiry date; lot# M047660, expiry date 02-DEC-2018; dose and route of administration not reported) for prophylaxis. Sterile diluent (unknown lot number and expiration date) used for reconstitution of VARIVAX was properly stored. No adverse effects were reported. Administered doses of vaccine were stored in -14 to -10 degrees Celsius for 1 hour and 30 minutes. There were no previous temperature excursions. The call was because of a "data logger".
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tonic-clonic seizures in a 19-year-old male patient who received BEXSERO. The patient's past medical history included cerebral palsy and seizure (but not had one in the past 5 years). On 20th August 2017, the patient received the 1st dose of BEXSERO. On 20th August 2017, less than a day after receiving BEXSERO, the patient experienced tonic-clonic seizures (serious criteria hospitalization and GSK medically significant) and fever (serious criteria hospitalization). The patient was treated with TYLENOL. On 20th August 2017, the outcome of the tonic-clonic seizures was recovered/resolved. On an unknown date, the outcome of the fever was unknown. The reporter considered the tonic-clonic seizures to be possibly related to BEXSERO. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: Around midnight of the vaccination day, the patient had a tonic-clonic seizure that lasted for about 10 minutes. His temperature was 37.8 C, but he had been given TYLENOL by his mother earlier. The patient was hospitalized and many tests were performed, but the physicians could not conclusively say the seizure was related to the vaccine.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Gingival swelling, Mouth swelling, Pyrexia, Stomatitis, Vomiting
Clinical narrative: Pt had vomiting at about 1 am the night she received vaccines and had a low grade fever and 3 days later pt's mouth and gums are swollen and has sores in the mouth.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: Patient received vaccine at our pharmacy on Monday afternoon and later that evening she sent to the ER complaining of a burning sensation in her lower back. She was given a prescription for Benadryl and came to the pharmacy Tuesday morning to get filled. Had no complaints of the burning sensation at that time.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: THE PATIENT CAME IN YESTERDAY SAYING THAT SHE IS HAVING A SIGNIFICANT AMOUNT OF PAIN FOLLOWING HER PREVNAR VACCINE GIVEN ON 9/3/17. SHE SAID THAT SHE CALLED ON 9/5 AND SPOKE TO A PHARMACIST REGARDING HOW HER ARM WAS QUITE SORE AND SHE WAS UNABLE TO LIFT HER ARM ABOVE HER HEAD WITHOUT BEING IN A SIGNIFICANT AMOUNT OF PAIN. THE PHARMACIST SHE SPOKE WITH SAID THAT IT IS MORE THAN LIKELY JUST NORMAL SORENESS AT THE INJECTION SITE POST VACCINATION AND TO GIVE IT UP TO A WEEK TO GO AWAY THEN CALL THE DOCTOR IF IT WORSENS OR DOESN'T IMPROVE. SHE CAME IN YESTERDAY SAYING THAT IT HAS IMPROVED SOME BUT SHE STILL IS UNABLE TO LIFT HER ARM ABOVE HER HEAD. I ASKED HER WHERE THE VACCINE WAS GIVEN AND SHE POINTED TO THE CENTER OF HER RIGHT DELTOID MUSCLE SO IT WAS ADMINISTERED IN THE CORRECT SPOT (NOT TOO HIGH). SHE SAID IT WAS NOT WARM OR RED SO MORE THAN LIKELY NOT AN INFECTION. I TOLD HER TO DEFFINITELY CALL HER PCP TO GET EVALUATED ASAP AND WE WILL REPORT ACCORDING TO PFIZER/WYETH AND VAERS. I CALLED THE PATIENT'S PCP TO INFORM HIM AS WELL AND THE NURSE INDICATED THAT SHE SPOKE TO THE PATIENT TO GET MORE INFORMATION AND WOULD RELAY ALL INFORMATION WITH THE DOCTOR ONCE HE BECAME AVAILABLE.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site discomfort, Joint range of motion decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: THE PATIENT CAME IN YESTERDAY SAYING THAT SHE IS HAVING A SIGNIFICANT AMOUNT OF PAIN FOLLOWING HER PREVNAR VACCINE GIVEN ON 9/3/17. SHE SAID THAT SHE CALLED ON 9/5 AND SPOKE TO A PHARMACIST REGARDING HOW HER ARM WAS QUITE SORE AND SHE WAS UNABLE TO LIFT HER ARM ABOVE HER HEAD WITHOUT BEING IN A SIGNIFICANT AMOUNT OF PAIN. THE PHARMACIST SHE SPOKE WITH SAID THAT IT IS MORE THAN LIKELY JUST NORMAL SORENESS AT THE INJECTION SITE POST VACCINATION AND TO GIVE IT UP TO A WEEK TO GO AWAY THEN CALL THE DOCTOR IF IT WORSENS OR DOESN'T IMPROVE. SHE CAME IN YESTERDAY SAYING THAT IT HAS IMPROVED SOME BUT SHE STILL IS UNABLE TO LIFT HER ARM ABOVE HER HEAD. I ASKED HER WHERE THE VACCINE WAS GIVEN AND SHE POINTED TO THE CENTER OF HER RIGHT DELTOID MUSCLE SO IT WAS ADMINISTERED IN THE CORRECT SPOT (NOT TOO HIGH). SHE SAID IT WAS NOT WARM OR RED SO MORE THAN LIKELY NOT AN INFECTION. I TOLD HER TO DEFFINITELY CALL HER PCP TO GET EVALUATED ASAP AND WE WILL REPORT ACCORDING TO PFIZER/WYETH AND VAERS. I CALLED THE PATIENT'S PCP TO INFORM HIM AS WELL AND THE NURSE INDICATED THAT SHE SPOKE TO THE PATIENT TO GET MORE INFORMATION AND WOULD RELAY ALL INFORMATION WITH THE DOCTOR ONCE HE BECAME AVAILABLE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Rash macular
Clinical narrative: About 24 hours after the patient received the PNEUMOVAX vaccination, her left arm got swollen with red blotchy patches from the top of her shoulder down to her elbow. Patient applied cool compresses and hydrocortisone cream on the areas. The red patches and swelling subsided after doing this. She still had some residual itching after.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 14-AUG-2017, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX 19400 PFU lot # N041510, expiration 27-JUL-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effects reported. No further information provided. Lot number N041510 has been verified to be a valid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant therapies and concurrent conditions was provided. The reporter stated that there was a possibility of product availability issue with RECOMBIVAX HB (lot # and expiration date were not reported). The reporter stated that a potential existed with the back order situation with RECOMBIVAX HB because since ENGERIX-B was 10 mcg. The dose of 10 mcg ENGERIX-B was needed to achieve pediatric dose, there was a possibility to administer two RECOMBIVAX HB doses of 0.5 mcg. There was also reported that there was circumstance or information capable of leading to medication error with RECOMBIVAX HB and ENGERIX-B. No adverse events were reported.
Age: 0.92
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antigen positive
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old female patient. No information regarding the patient's pertinent medical history provided, patient with no drug reactions or allergies. Concomitant medications reported is medication for acne (no further information). It was reported that the patient was vaccinated with three dose series of the pediatric formulation of RECOMBIVAX lot number unknown. The patient received first dose 11-APR-1997, second dose on 13-MAY-1997 and third dose on 12-MAR-1998. On 07-NOV-2015 a hepatitis B titer was drawn and showed result of "not reactive." In addition to three dose series of the pediatric formulation of RECOMBIVAX, the patient was vaccinated with one dose of the adult formulation of RECOMBIVAX (lot J013394 exp 08/25/2016) on 29-DEC-2015 and a second dose on 05-APR-2016 (lot L029631 exp 01/14/2017). On 18-AUG-2017, hepatitis B titer was done and showed a result of a surface antigen of 1000. No further information provided.  Additional information requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified 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 29-AUG-2017, the patient was vaccinated with one improperly stored dose of PNEUMOVAX 23 (route of administration was not reported) lot # N010106 and expiration date: 15-NOV-2018. No adverse effects were reported. The vaccine was exposed to temperature from 47 to 77 degrees Fahrenheit for 1 hour and 20 minutes, which was detected by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N008828, expiration date 16-MAR-2019 (dose and route of administration were not reported) for prophylaxis. Concomitant therapy included properly stored sterile diluent (MERCK). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (also reported as 6.8 degrees Fahrenheit) for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA005371.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 68-years-old consumer who refers on herself. There was no information about the patient's medical history provided. The patient did not have any known drug reactions or allergies. The patient's concurrent conditions included high blood pressure. The patient's concomitant therapies included CRESTOR and an "unspecified blood pressure medication". On an unspecified date in 2013, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, frequency, lot# and expiration date were not reported) for prevention of herpes zoster. On 03-SEP-2017, the patient was diagnosed with shingles when she saw an "express urgent care" physician. The physician stated the patient "has shingles on her back". The patient was put on VALTREX to treat the shingles. There were no lab diagnostic studies performed. The patient was concerned that because she was "near her grandson if he will contract anything" and in addition wanted to know if she "need a revaccination for herself and her husband". The outcome of shingles was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a nurse referring to a 11 year old female patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions was not reported. The patient did not have concomitant medications. On 29-AUG-2017, the patient was vaccinated with GARDASIL 9 (strength, dose, lot number and expiration date were not reported), by intramuscular route for prevention of human papilloma virus (HPV). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine, tetanus toxoid (manufacturer unknown) and meningococcal vaccine (manufacturer unknown) in the opposite arm (unspecified). The same day after vaccination the patient fainted. The patient's vitals were checked, and coherence questions were asked and a popsicle was given. The patient recovered 30 minutes after vaccination. The causality assessment between GARDASIL 9 and the event was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date) in the series and then received a second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date) 5 months later on 09-JUN-2017. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients might have been vaccinated with VARIVAX lot# M027342, expiration date 01-JUN-2018; lot# N001527, expiration date 13-JAN-2019; lot# M034586, expiration date 27-JUL-2018; lot# M041514, expiration date 11-OCT-2018 (strength, dose and route of administration were not reported) for prophylaxis. Concomitant therapies included sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 Fahrenheit degrees and 46 Fahrenheit degrees within the range of 30.4 Fahrenheit degrees for 16 hours. Digital data logger was used to capture temperature excursions. There were no previous temperature excursions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA005627.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients might have been vaccinated with PROQUAD lot# M038228, expiration date 06-MAR-2018; lot# M049123, expiration date 13-JUN-2018; lot# N008825, expiration date 12-SEP-2018; lot# M035689, expiration date 06-FEB-2018; lot# M041509, expiration date 09-APR-2018 (strength, dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 Fahrenheit degrees and 46 Fahrenheit degrees with the range of 30.4 Fahrenheit degrees for 16 hours. Digital data logger was used to capture temperature excursions. There were no previous temperature excursions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA005417.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Cough, Erythema, Neck pain, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 17 years old female patient received the first single dose of TRUMENBA on an unspecified date for immunization. Medical history and concomitant medications were not provided. On an unspecified date after vaccination the patient experienced fever at 101.2, sore neck, congestion, cough, localized arm swelling extreme with heat and redness. Events outcome was unknown.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Respiratory tract congestion, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 17 years old female patient received the first single dose of TRUMENBA on an unspecified date for immunization. Medical history and concomitant medications were not provided. On an unspecified date after vaccination the patient experienced fever at 101.2, sore neck, congestion, cough, localized arm swelling extreme with heat and redness. Events outcome was unknown.
Sex: F
Vaccine: MENB
Symptoms: Confusional state, Dizziness, Headache, Pain, Pollakiuria
Clinical narrative: This is a spontaneous report from two contactable physicians via a Pfizer representative. A female patient of an unspecified age and race/ethnicity received the first dose of TRUMENBA on an unspecified date, at 0.5 ml single, for immunisation. No other vaccines were given on that day. The patient medical history and concomitant medications were not reported. On an unspecified date, immediately after vaccination, the patient experienced urination every hour for 48 hours, dizzy, headache, confusion, body aches and fever. The patient was not taken to the ER. The events resolved on an unspecified date.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from two contactable physicians via a Pfizer representative. A female patient of an unspecified age and race/ethnicity received the first dose of TRUMENBA on an unspecified date, at 0.5 ml single, for immunisation. No other vaccines were given on that day. The patient medical history and concomitant medications were not reported. On an unspecified date, immediately after vaccination, the patient experienced urination every hour for 48 hours, dizzy, headache, confusion, body aches and fever. The patient was not taken to the ER. The events resolved on an unspecified date.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Erythema infectiosum, Measles post vaccine, Pruritus, Pyrexia, Rash
Clinical narrative: 9/8/2017 child had fever of 100.4 slight very light rash, 9/9/17 no fever, child playing normally rash still very light barely noticeable per foster mom. 9/10/17 rash more red and over trunk, extremities and face fever 99.7. Took child to after hours clinic diagnosed with 5th disease. 9/11/17 child taken to Dr with rash, low grade temp, Dr & Dr diagnosed child with measles, based on symptoms, no testing performed. 9/12/17 spoke to mom child has no fever and rash almost resolved but has some itching.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Rash erythematous
Clinical narrative: 9/8/2017 child had fever of 100.4 slight very light rash, 9/9/17 no fever, child playing normally rash still very light barely noticeable per foster mom. 9/10/17 rash more red and over trunk, extremities and face fever 99.7. Took child to after hours clinic diagnosed with 5th disease. 9/11/17 child taken to Dr with rash, low grade temp, Dr & Dr diagnosed child with measles, based on symptoms, no testing performed. 9/12/17 spoke to mom child has no fever and rash almost resolved but has some itching.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Feeling abnormal, Measles, Pyrexia, Urticaria
Clinical narrative: 9/8/2017 child had fever of 100.4 slight very light rash, 9/9/17 no fever, child playing normally rash still very light barely noticeable per foster mom. 9/10/17 rash more red and over trunk, extremities and face fever 99.7. Took child to after hours clinic diagnosed with 5th disease. 9/11/17 child taken to Dr with rash, low grade temp, Dr & Dr diagnosed child with measles, based on symptoms, no testing performed. 9/12/17 spoke to mom child has no fever and rash almost resolved but has some itching.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Lichenification, Peripheral swelling
Clinical narrative: Well demarcated redness and swelling from proximal right shoulder to just distal to right elbow. There is lichenification and skin thickening.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Skin hypertrophy
Clinical narrative: Well demarcated redness and swelling from proximal right shoulder to just distal to right elbow. There is lichenification and skin thickening.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: RED RASH AROUND INJECTION SITE AND COVERING GOOD SIZE OF UPPER ARM. PATIENT STATED RASH IS 'HOT TO TOUCH'. PATIENT IS GOING TO URGENT CARE AND MAY RECEIVE A PRESCRIPTION FOR ANTIBIOTICS.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Cough, Erythema, Fatigue, Infection
Clinical narrative: RED RASH AROUND INJECTION SITE AND COVERING GOOD SIZE OF UPPER ARM. PATIENT STATED RASH IS 'HOT TO TOUCH'. PATIENT IS GOING TO URGENT CARE AND MAY RECEIVE A PRESCRIPTION FOR ANTIBIOTICS.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Skin warm, Urticaria
Clinical narrative: RED RASH AROUND INJECTION SITE AND COVERING GOOD SIZE OF UPPER ARM. PATIENT STATED RASH IS 'HOT TO TOUCH'. PATIENT IS GOING TO URGENT CARE AND MAY RECEIVE A PRESCRIPTION FOR ANTIBIOTICS.
Age: 27.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Loss of consciousness, Muscle spasms
Clinical narrative: Loss of consciousness. Severe muscular spasms around spine, neck to sacrum.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm became swollen, sore, and developed a fever.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Headache, Injection site bruising
Clinical narrative: Headaches, chest tightness. There is purple bruising size of half dollar at the site of injection.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Pain in extremity, Skin warm
Clinical narrative: Left arm began to hurt, get extremely red, and feel very warm later in the evening on day of vaccine. The redness began to cover a large portion of the arm. Patient came in Monday and reported discomfort and showed RPh the arm. Advised to continue icing arm and take oral analgesics. Called patient Tuesday morning and was informed it appeared a bit better but still bothered by it. Patient stated they had made MD visit for later in the day.