chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a 41-year-old female patient who received BOOSTRIX (batch number EC9A9, expiry date 22nd January 2019). On 30th January 2017, the patient received BOOSTRIX 0.5 ml. On 31st January 2017, 1 days after receiving BOOSTRIX, the patient experienced blurred vision. The patient was treated with vitamins nos. On an unknown date, the outcome of the blurred vision was unknown. The reporter considered the blurred vision to be unrelated to BOOSTRIX. Additional details were provided as follows: On 30th January 2017, the patient received BOOSTRIX vaccine around approximately 7pm and upon awaking on the morning of 31st January 2017 experienced the blurry vision and had difficulty for focusing on objects (visual disturbances). The patient received vitamins and herbs and the symptoms went away. Edit (not further specified), pharmacist who took the escalated call and told that the health care professional stated that two weeks ago the patient drank out of a cup from someone who had Guillain Barre Syndrome.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden. On 23rd November 2016, the patient received Influenza vaccine Quadrivalent. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were unchanged. The reporter considered the pain in arm an injected limb mobility decreased to be related to Influenza vaccine Quadrivalent . Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The patient was administered a Glaxo Smith Kline's Quadrivalent Flu vaccine in her left arm but it was not known which flu vaccine was given. Within a week, the patient's arm was sore and tender. The problem with the patient's arm was worsened. Within three weeks, the patient was unable to lie down on her left arm. The range of motion for her arm was decreased and she had difficulty in reaching. A 25mg gauge needle was used. Due to the continuing problems with the arm, the patient's primary doctor had referred her to an orthopaedist and classified it as an injury to her arm. The patient worked in the doctor's office. The sales representative could not provide the health care professional's address, lot number, expiration date or any additional information. The representative stated that she spoke to medical information on behalf on this doctor at the time of reporting but did not report the adverse event to them.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLUARIX QUADRIVALENT. On 13th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. In October 2016, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. This case was not associated with any medication error. This case has been linked with US2016GSK160436, reported by same reporter.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Ankylosing spondylitis, Asthenia, Fatigue, HLA-B*27 positive, Paraesthesia
Clinical narrative: Developed paresthesias, weakness and fatigue following anthrax immunizations and received Dx of ankylosing spondylitis. Feels AVA caused AS. Causality assessment resulted in only temporal relationship.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received FLULAVAL Quadrivalent (batch number AE735, expiry date unknown). On 23rd November 2016, the patient received FLULAVAL Quadrivalent. On an unknown date, less than a year after receiving FLULAVAL Quadrivalent, the patient experienced pain in arm an injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were unknown. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The emergency room visit was required. The patient received FLULAVAL Quadrivalent in left shoulder. At the time of reporting, the health care professional reported that patient experienced pain, difficulty moving the arm over the past month from the date of reporting, the patient can't sleep on the arm, had deep pain and soreness of the arm. The patient was scheduled to see an orthopaedic surgeon, and was seen by her primary care physician on 2 dates, which were unknown at the time of the reporting. Expiration date was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Meningitis aseptic, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Influenza, Lumbar puncture abnormal, Meningitis aseptic, Mononucleosis heterophile test positive
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful.
Sex: F
Vaccine: RV1
Symptoms: Device breakage, Laceration, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of laceration of finger in a adult female patient who received ROTARIX (lyophilized formulation) (batch number 94F25, expiry date 16th July 2018). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the laceration of finger to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: This case was associated with the product complaint. The age at vaccination was not reported. The caller reported that the nurse cut her finger on a cracked vial of ROTARIX powder. The nurse was fine at the time of reporting and a Band-Aid was applied on the finger.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: None stated.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Hypoaesthesia, Peripheral coldness, Peripheral swelling
Clinical narrative: Had flu shot in left arm and as it was given my arm went numb, my hand got really cold. After that I was in severe pain and my arm swelled. Told the pharmacist about it and she said that can happen. I have had many flu shots, but none like this I ended up that weekend at a walk in clinic getting a cortisone shot and a MEDROL pack. Still hurting after a month and living on ALEVE. Cant continue this. Still have severe pain.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Paraesthesia, Peripheral coldness, Peripheral swelling
Clinical narrative: Had flu shot in left arm and as it was given my arm went numb, my hand got really cold. After that I was in severe pain and my arm swelled. Told the pharmacist about it and she said that can happen. I have had many flu shots, but none like this I ended up that weekend at a walk in clinic getting a cortisone shot and a MEDROL pack. Still hurting after a month and living on ALEVE. Cant continue this. Still have severe pain.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Hypoaesthesia, Pain, Peripheral coldness, Peripheral swelling
Clinical narrative: Had flu shot in left arm and as it was given my arm went numb, my hand got really cold. After that I was in severe pain and my arm swelled. Told the pharmacist about it and she said that can happen. I have had many flu shots, but none like this I ended up that weekend at a walk in clinic getting a cortisone shot and a MEDROL pack. Still hurting after a month and living on ALEVE. Cant continue this. Still have severe pain.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Fatigue, Full blood count, Headache
Clinical narrative: Tired, Sleepy, Chills, Fever, Sweats, Constant Diarrhria, headache. I slept and had the runs for 5 days. On the 6th day I went to the hospital for intraveneous fluids.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Hyperhidrosis, Pyrexia, Somnolence
Clinical narrative: Tired, Sleepy, Chills, Fever, Sweats, Constant Diarrhria, headache. I slept and had the runs for 5 days. On the 6th day I went to the hospital for intraveneous fluids.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Can barely use left arm, can not put my clothes on can not pick up a cup of water hurt like hell can not sleep on my left side anymore hurts hurts 24 hours a day on a scale of 1 to 10 10 being the worst my pain is 9.5.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 30-JAN-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L002215 with expiration date 21-JAN-2017, subcutaneously (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 32 years old patient of an unknown gender. There were no concurrent conditions, medical history or concomitant medications reported. On 26-JAN-2017, the patient was vaccinated with a dose of PROQUAD (dose, frequency and route not reported; lot # and expiration date were unspecified) for prophylaxis, which was outside of the recommendations in the PROQUAD prescribing information. No adverse effect was reported. No product quality complaint was involved (PQC). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 3 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # M024261, expiration date 05-FEB-2019) (dose and route of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 24 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old, non-pregnant, female patient. The patient's pertinent medical history included seasonal allergies. She did not take any concomitant medications and had no drug reactions and/or allergies. On 22-JAN-2017, the patient was vaccinated with GARDASIL 9, lot # M023169, expiry date 13-JUN-2018 (dose, route and site of administration were not reported) for prophylaxis. On 08-FEB-2017, the patient called the physician's office to report redness, swelling, pain and a hard raised area at the injection site after receiving the vaccine. The patient was also unable to raise her arm above her shoulder due to pain. No treatment was given for the events. The events were reported as not recovered at the time of the report. The reporter requested lot check. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004017.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 year old, female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapies or medical history provided. On 13-NOV-2015 at 2 pm., the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. The patient did not have any illnesses at the time of vaccination. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion that the administered VARIVAX experienced were not reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004105: US-009507513-1702USA004106: US-009507513-1702USA004107: US-009507513-1702USA004108: US-009507513-1702USA004109: US-009507513-1702USA004110: US-009507513-1702USA004103: US-009507513-1611USA008278.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report, as received from a registered nurse, refers to a patient of unknown gender and unknown age. No concurrent conditions or medical history were reported. On 10-FEB-2017, the patient was vaccinated with one dose of VARIVAX 1 dosage form (formulation, dosage and route of administration were not reported, lot number: L042265, expiration date: 26-OCT-2017) for prophylaxis. No concomitant therapies were reported. On unknown dates, prior to administration, the dose of the VARIVAX had been improperly stored, according to a digital data logger (DDL). The DDL indicated that the vaccine had been stored at 9 degrees Fahrenheit for 40 minutes; at more than 5 degrees Fahrenheit, but less than 14 degrees Fahrenheit for 6 minutes; at more than 14 degrees Fahrenheit, but less than 46 degrees Fahrenheit for 1 hour and 48 minutes; at more than 46 degrees Fahrenheit, but less than 77 degrees Fahrenheit for 2 hours and 42 minutes. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Breast pain, Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her 20's. The patient had an increased risk of pneumococcal disease due to smoking. In October 2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular (lot #, expiration date, dose and site of administration were not reported) and an unspecified flu vaccine for prophylaxis. On an unknown date, the patient experienced redness, swelling, and soreness from the shoulder to the elbow and soreness in the breast on an unspecified side. The outcome of events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006102: US-009507513-1702USA006265: US-009507513-1702USA006019.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Product quality issue, Vaccination failure
Clinical narrative: This spontaneous report was received from Pfizer Inc and was assigned manufacturer report number (2017048505) for PREVNAR 13. This was originally reported by a currently 70-year-old female patient with sleeping disorder, who refers to herself. The patient's medical history were not reported. In January 2015, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot number, expiration date were not reported) for prophylaxis, per physician's recommendation. Concomitant medication included zolpidem. No longer than five weeks after receiving pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the blood test was done to see if her resistance to pneumonia went up. The doctor explained to her that in his entire career he had never seen this, the patient entire chart was exactly the same after the vaccination. She finally got that she was not protected from pneumonia by vaccine (Vaccination failure). Her titer was less than 3 (unit not provided), low (nothing, non existent protection) (Antibody test negative). She should have had more protection, but did not find anything after she had a titer. It was also reported that the titer was less than 4 (unit not provided). The dose of vaccine was watered down (Product quality issue) and did not work (Vaccination failure). The outcome of the events was not reported. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009794.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot number reported as M001569, expiration date: 30-SEP-2017 (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that PROQUAD was exposed to a temperature of >5 Farenheit degrees but <14 Farenheit degrees for 2 hours and 4 minutes. There was a previous temperature excursion of >5 Farenheit degrees but <14 Farenheit degrees for 1 hour and 13 minutes for PROQUAD, this excursion was detected due to a data logger. No adverse effect were reported. Lot number M001569 is an invalid lot number for PROQUAD. This is one of the several reports of the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001816.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: This spontaneous report was received from Pfizer Inc and was assigned manufacturer report number (2017048505) for PREVNAR 13, concerning a male patient of unknown age. This was originally reported by a patient's wife. The patient's concurrent conditions, medical history and concomitant medications were not reported. In January 2015, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot number, expiration date were not reported) for prophylaxis. After receiving pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the blood test was done and there was no reaction on data. The reporter stated that her husband did not have any protection from pneumonia. The dose of vaccine did not work (Vaccination failure). The titer was less than 4 (unit not provided) (Antibody test negative). Product quality complaint was involved. The outcome of the events was not reported. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008462.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from consumer via Pfizer (Manufacture report number: 201655470) on 09-FEB-2017. The case is linked with 2017SA025687 and 2017SA025701 (same reporter). This case involves a male patient (Age not reported) who was vaccinated with a first dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient was sick more times in about eight months or so than he normally gets in two years. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: RT ARM SWELLING AND REDNESS, AREA 8.5CM X 8CM. TREATED WITH BENADRYL AND COOL COMPRESSES. RECEIVED MENVEO IN RIGHT ARM.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Mom noticed redness/warmth at injection site the evening after he got the vaccine. Course worsened over the following 2 days. When examined - erythema noted on L anterior thigh, 11cm x 9.5cm with 0.5 cm central induration. Slight warmth to touch.
Age: 24.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Arthralgia, Chest X-ray normal, Chest discomfort, Dyspnoea, Full blood count normal
Clinical narrative: Called 2/9/17 to report nausea, body and joint/muscle aches, feverish and irritability.  Sent to ER on 2/14 still c/o symptoms + shortness of breath and chest discomfort.  In ER given IV fluids and Toredol for pain, blood work (all WNL) and was discharged home on rest ^fluids.  Appt,3/16 scheduled to see ID MD.  Pt did not show - states symptoms resolved.
Age: 24.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Irritability, Laboratory test normal, Myalgia, Nausea, Pain
Clinical narrative: Called 2/9/17 to report nausea, body and joint/muscle aches, feverish and irritability.  Sent to ER on 2/14 still c/o symptoms + shortness of breath and chest discomfort.  In ER given IV fluids and Toredol for pain, blood work (all WNL) and was discharged home on rest ^fluids.  Appt,3/16 scheduled to see ID MD.  Pt did not show - states symptoms resolved.
Age: 24.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Pyrexia
Clinical narrative: Called 2/9/17 to report nausea, body and joint/muscle aches, feverish and irritability.  Sent to ER on 2/14 still c/o symptoms + shortness of breath and chest discomfort.  In ER given IV fluids and Toredol for pain, blood work (all WNL) and was discharged home on rest ^fluids.  Appt,3/16 scheduled to see ID MD.  Pt did not show - states symptoms resolved.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Laboratory test normal, Myalgia, Pain, Pain in extremity
Clinical narrative: This spontaneous report has been received from a currently 74 years old female patient reporting on herself, patient with asthma and unspecified allergic condition. Information regarding medical history, and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, intravenously (strength, dose, frequency, anatomical location, lot# and expiration date were not provided) for prophylaxis. On an unknown date, within 24 hours of the vaccination, the patient experienced "excruciating pain in her arm", after removed her shirt she noticed that her arm "was swollen about 50% larger than normal and also she had a "big welt on her arm that turned white". Therefore she contacted her physician and went back for a check up, the physician was given BENADRYL and unspecified OTC medicine to help the pain subside. Several days after, the patient began experiencing "muscle or joint pain" in her arms legs and buttocks, as result of she returned to saw the physician once again, and unspecified test were performed to see what was causing the persistent body aching, however her physician was not able to located any findings from these tests. At the time of the reporting the patient continued with the treatment and the outcome of pain in her arm, muscle or joint was recovering, and the outcome of swollen arm and big welt on her arm was reported as unknown. The reporter considered pain in extremity, arthralgia and myalgia to be related to PNEUMOVAX 23. Additional information is not expected since the reporter did not consent for follow-up attempts.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: This spontaneous report has been received from a currently 74 years old female patient reporting on herself, patient with asthma and unspecified allergic condition. Information regarding medical history, and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, intravenously (strength, dose, frequency, anatomical location, lot# and expiration date were not provided) for prophylaxis. On an unknown date, within 24 hours of the vaccination, the patient experienced "excruciating pain in her arm", after removed her shirt she noticed that her arm "was swollen about 50% larger than normal and also she had a "big welt on her arm that turned white". Therefore she contacted her physician and went back for a check up, the physician was given BENADRYL and unspecified OTC medicine to help the pain subside. Several days after, the patient began experiencing "muscle or joint pain" in her arms legs and buttocks, as result of she returned to saw the physician once again, and unspecified test were performed to see what was causing the persistent body aching, however her physician was not able to located any findings from these tests. At the time of the reporting the patient continued with the treatment and the outcome of pain in her arm, muscle or joint was recovering, and the outcome of swollen arm and big welt on her arm was reported as unknown. The reporter considered pain in extremity, arthralgia and myalgia to be related to PNEUMOVAX 23. Additional information is not expected since the reporter did not consent for follow-up attempts.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates since 05-JAN-2017, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number M025193, expiration date 21-MAR-2019 and lot number reported as M036058, expiration date 19-MAY-2019 (dose and route of administration were not provided) for prophylaxis. The reporter had not been informed of any adverse effects. Administered doses of LIQUID PEDVAXHIB were exposed to a temperature excursion between 32°F and 36°F (34°F) for 3 hours and 3 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments: US-009507513-1702USA010194: US-009507513-1702USA010195:
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2009, the patient was vaccinated with PNEUMOVAX23 (dosage regimen, frequency, lot # and expiry date not reported) for prophylaxis. On an unknown date in 2009 the patient had a bad reaction to PNEUMOVAX23. The pharmacist was now concerned if she could go ahead and take PREVNAR 13. The outcome of bad reaction was unknown. The reporter did not provide the causality assessment for event with PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received based on an inferring from an article of a newspaper via an unspecified source and through a company representative refers to an unspecified number of patients of unknown age and gender who were all children. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, on unknown dates, the patients had been vaccinated with M-M-R II for prophylaxis (the dose, dosage number, route of administration, lot #, expiration date, therapy type and anatomical location were unknown). The article claimed that varying sources seemed to suggest that the vaccine caused autism, on unknown dates, in these children (who were one in 66 (also stated as 68) of those who were vaccinated with M-M-R II. Apparently, it was also stated that various other studies conducted showed that there was no relationship between the vaccination and autism and that while the rates of autism had risen since the year 200, this was due to better awareness of the disease and changes in the way it was diagnosed. Upon internal review, the event of autism was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates since 05-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number M034780, expiration date 15-APR-2019 and lot number M005714, expiration date 03-OCT-2017 (dose and route of administration were not provided) for prophylaxis. The reporter had not been informed of any adverse effects. Administered doses of GARDASIL 9 were exposed to a temperature excursion between 32°F and 36°F (34°F) for 3 hours and 3 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA004300: US-009507513-1702USA010195.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates since 05-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot number M038728, expiration date 25-APR-2018 and lot number reported as M006112, expiration date 16-NOV-2017 (dose and route of administration were not provided) for prophylaxis. The reporter had not been informed of any adverse effects. Administered doses of ROTATEQ were exposed to a temperature excursion between 32°F and 36°F (34°F) for 3 hours and 3 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA004300: US-009507513-1702USA010194.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M042504, expiration date: 30-NOV-2017) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit (F) >14°F but < 46°F for 14 hours and 24 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-US-009507513-1702USA002724.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Guillain-Barre syndrome
Clinical narrative: Initial unsolicited case received from a nurse on 13 Feb 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (HD) (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient relevant medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient developed Guillain-Barre. The patient relevant lab tests and corrective treatment was not reported. The outcome of the events was not reported. Upon internal review the company decided to consider the event as serious due to important medical event Guillain-Barre syndrome. List of documents held by sender: none.; Sender's Comments: This case is poorly documented. No information is provided on time to onset, symptoms and their evolution. Further information regarding Guillain-Barre syndrome diagnosis confirmation (cerebrospinal fluid and electrophysiological analyses, absence of tendon reflexes, information on limbs weakness, information on the development of the disease i.e. monophasic pattern or not) and infectious work up to confirm the reported absence of concurrent infection are needed for complete assessment of the case.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Pain, Peripheral swelling, Rash
Clinical narrative: Redness has spread to elbow, soreness,  extreme swelling, rash, arm is hot, hand swelling upset stomach.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Redness has spread to elbow, soreness,  extreme swelling, rash, arm is hot, hand swelling upset stomach.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Malaise, Muscle spasms
Clinical narrative: She started to get headaches and just over all ill feeling. Her cramps are unbearable.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient was given zoster vaccine instead of varicella vaccine. This was suppose to be the patient's 2nd dose. I have reported error to clinic I care  to my patient care supervisor, and discuss with an provider.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Localized redness and pain.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: My upper left arm muscle where the Flu Shot was administered has been aching me ever since, with a gnawing pain and I have limited movement & use of my left arm because of the pain. If I try to use my left arm, the pain increases in its intensity & therefore I have to avoid using it, moving it, or even laying on it!
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: My upper left arm muscle where the Flu Shot was administered has been aching me ever since, with a gnawing pain and I have limited movement & use of my left arm because of the pain. If I try to use my left arm, the pain increases in its intensity & therefore I have to avoid using it, moving it, or even laying on it!
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse 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 an unknown date in March 2016, the patient was vaccinated with a dose of  GARDASIL 9 first dose (dose, route and site of administration, lot # and expiry date were not reported). On unknown dates in July 2016 and August 2016, the patient was vaccinated with the second and third dose of GARDASIL 9, respectively. No product quality complaint was involved. 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 registered nurse 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 30-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot #  M009378 with expiry date of 23-APR-2018 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 31 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported. Additional information is not expected as there was no consent to contact physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M042504, expiration date: 30-NOV-2017) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit (F) >14°F but < 46°F for 14 hours and 24 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA010198:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 07-FEB-2017, the patient was vaccinated with a dose of VARIVAX, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 09-FEB-2017 from a nurse regarding an unknown number of unspecified patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not provided. On unspecified dates, an unknown number of unspecified patients received doses of RECOMBIVAX HB lot # M020926, expiration 11-AUG-2018, "single dose", intramuscular for prophylaxis that had been improperly stored. The vaccine doses were stored at 35F for 8 hours and there was no previous temperature excursion. No adverse effects reported. No further information was reported. Additional information is not expected because the reporter refused consent to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and a registered nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. Since 24-JAN-2017, the patients had been vaccinated with an improperly stored VARIVAX vaccines, lot # L042265, expiration date: 26-OCT-2017 and lot # M024702, expiration date: 18-MAY-2018 (dose and route of administration were not reported) for prophylaxis with a temperature greater than 5 Fahrenheit degrees and less than 14 Fahrenheit degrees for 84 minutes. Additionally, previous temperature excursions were reported on an unspecified dates: greater than 5 Fahrenheit degrees but less than 14 Fahrenheit degrees for 6 minutes, greater than 14 Fahrenheit degrees but less than 46 Fahrenheit degrees for 1 hour and 48 minutes, greater than 46 Fahrenheit degrees but less than 77 Fahrenheit degrees for 2 hours and 42 minutes. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009295.
Age: 10.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 03-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
Age: 3.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that, on 23-JUL-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case). Previous temperature excursion: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case). The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005376.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 05-AUG-2015, the patient was vaccinated with the first dose of GARDASIL, (lot number and expiration date were not reported) then on 21-FEB-2017, the patient was vaccinated with the second dose of GARDASIL 9 lot number M024261 with expiration date 30-JUL-2018, (dose, route and anatomical location were not reported for the both vaccines above described) both for prophylaxis. No adverse effects were reported. Additional information has been requested.