chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself.  This 75-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single in the left arm on 24Jun2016 for immunisation. Medical history included ongoing diabetes (diagnosed in the late 1980's to early 1990's), blood potassium abnormal, pancreatitis in Mar2015 (hospitalized). Concomitant medication included insulin human, insulin human injection, isophane (NOVOLIN) subcutaneous 15 units injection twice daily for diabetes, losartan oral 1 DF daily for potassium, metformin oral 1000 mg, 2x/day for diabetes, atorvastatin oral 10 mg, 1x/day, all since 2015 and ongoing. The patient previously took influenza vaccine in 1966 and as a result had the worst case of the flu, pneumococcal vaccine for immunisation. The patient experienced vomiting on Jun2016 with outcome of recovered, coughing on 26Jun2016 with outcome of recovered. The patient reported that PREVNAR 13 had a strange looking syringe. She went back to the pharmacy because of the bad reaction to find out what it was they gave her. They said they sent the pharmacist to another store. It was a short syringe and it looked like a horses saddle.  It was covered and brown in color. She had never seen a syringe like it before, like it had a saddle over it. She thinks she may have been given a Flu Vaccine. The patient underwent lab tests and procedures which included blood glucose: 445 on an unspecified date, blood glucose: 175 on 24Jun2016, chest x-ray: negative on 17Aug2016, influenza virus test: negative on Jun2016.  Therapeutic measures were taken as a result of coughing included Amoxicillin and Benzonatate but they did not work for her cough. She was given an inhaler, Asmanex, one puff as needed on 17Aug2016 for coughing and she started feeling funny. The Asmanex inhaler sent her blood sugar crazy. Then her blood sugar went up to 445. She does not remember having a blood sugar like that.  She was told that it has a steroid in it that was causing her blood sugar to go up, so she stopped using the product on 19Aug2016. The consumer subsequently confirmed that no new events occurred and stated a product complaint was filed. She received a prepaid package with a jar to send product back. Consumer stated she does not have the product to send back.  Follow-up (08Sep2016): New information reported form a contactable Consumer includes: no new event confirmed; product complaint filed.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Cellulitis, Erythema, Injection site pain, Pain, Swelling
Clinical narrative: Diagnosed in the emergency department with cellulitis at the injection site.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Diagnosed in the emergency department with cellulitis at the injection site.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 70 years old female patient regarding herself. Patient had no pertinent medical history. Information on drug reactions/allergies was unknown. On 16-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular in the left arm (lot # M018766). Patient had no concomitant medications. On 17-SEP-2016 (reported as 24 hours after vaccination), the patient experienced pain, swelling and itching in the left arm. The patient sought medical attention by visiting the urgent care. No treatment was given for the events. No lab diagnostics studies were performed. No product quality complaint was involved. Patient present status was reported as recovering. Causality was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a 70 years old female patient regarding herself. Patient had no pertinent medical history. Information on drug reactions/allergies was unknown. On 16-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular in the left arm (lot # M018766). Patient had no concomitant medications. On 17-SEP-2016 (reported as 24 hours after vaccination), the patient experienced pain, swelling and itching in the left arm. The patient sought medical attention by visiting the urgent care. No treatment was given for the events. No lab diagnostics studies were performed. No product quality complaint was involved. Patient present status was reported as recovering. Causality was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: 7/11/2016 had Grand Mal seizure. Treated by Neurologist. Currently on KEPPRA. No further seizures, including with second dose of vaccination.
Age: 18.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: 7/11/2016 had Grand Mal seizure. Treated by Neurologist. Currently on KEPPRA. No further seizures, including with second dose of vaccination.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Fatigue, Nausea, Pain in extremity
Clinical narrative: Swelling and inflammation in all major joints. Flexibility & range of motion severely restricted. Worst between 3 AM and 2 PM. Some days better than others.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthritis, C-reactive protein increased, Joint range of motion decreased, Joint swelling, Platelet count increased
Clinical narrative: Swelling and inflammation in all major joints. Flexibility & range of motion severely restricted. Worst between 3 AM and 2 PM. Some days better than others.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: This spontaneous report as received from a 66 year old female patient reporting on herself via Pfizer. The patient's concurrent condition included type 2 diabetes diagnosed in 2011 and an unspecified cholesterol disorder (reported as "cholesterol"). On 13-JUL-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). Other suspect vaccine received on 26-JUL-2016, included PREVENAR 13 injection, 1 dose in arm (exact dose, lot #, expiration date and route of administration were not provided). Concomitant therapies included metformin and pravastatin. On 12-SEP-2016, chest X-ray was performed and on 13-SEP-2016, she was diagnosed with pneumonia (also reported as "that was what it was shown"). The patient was not hospitalized, however she received ZITHROMAX as a treatment. The patient asked why PREVENAR 13 did not help her. The outcome of pneumonia was unknown. Causality assessment was not provided. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abasia, Blood test, Dysstasia, Injection site pain, Joint effusion
Clinical narrative: My son complained of leg pain, about an hour later he could no longer stand up on his own.  At about 2:00 AM he woke up screaming that his legs hurt and could no longer walk.  We rushed to hospital.  He was diagnosed with synovitis, fluid in his hip joints. He is still recovering.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Screaming, Synovitis, Ultrasound scan
Clinical narrative: My son complained of leg pain, about an hour later he could no longer stand up on his own.  At about 2:00 AM he woke up screaming that his legs hurt and could no longer walk.  We rushed to hospital.  He was diagnosed with synovitis, fluid in his hip joints. He is still recovering.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Blindness, Cerebral ischaemia, Headache, Hypertensive crisis
Clinical narrative: Vertigo, vomiting, headache, weakness, tingling around mouth and tingling left and right hand, weakness left hand, loss of vision left and right eyes, hypertensive crisis.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Paraesthesia oral, Vertigo
Clinical narrative: Vertigo, vomiting, headache, weakness, tingling around mouth and tingling left and right hand, weakness left hand, loss of vision left and right eyes, hypertensive crisis.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vomiting
Clinical narrative: Vertigo, vomiting, headache, weakness, tingling around mouth and tingling left and right hand, weakness left hand, loss of vision left and right eyes, hypertensive crisis.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Dizziness, Erythema, Headache, Migraine, Panic attack
Clinical narrative: 11:37 initally slightly lightheaded, arm tight feeling, 11:39 L arm starting to itch, refused benadryl a few times. 11:41 starting to feel a little dizzy, offered to lay her down, she was sitting, refused. Headache beginning, dizzy, a little hard to focus. states she suffers with panic attacks on occasions. Arm more itch and throat a little itchy - Administered diphenhydramine liquid orally 25mg at 11:46pm.  11:53 itching , redness on L arm and throat improving - feeling sleepy. 11:53 BP 113/80, pulse 88.  offered another dose of diphenydramine; declined due to drowsiness. She insisted on going home to rest- her father came to get her aprox 12:30am.  She has family to keep an eye on her also. Has a migraine, sleepy, tightness in Left arm. I advised seeking emergency treatment if symptoms get worse and to update the pharmacy after she is feeling better. I will also follow up with her as discussed.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pruritus, Skin tightness, Somnolence
Clinical narrative: 11:37 initally slightly lightheaded, arm tight feeling, 11:39 L arm starting to itch, refused benadryl a few times. 11:41 starting to feel a little dizzy, offered to lay her down, she was sitting, refused. Headache beginning, dizzy, a little hard to focus. states she suffers with panic attacks on occasions. Arm more itch and throat a little itchy - Administered diphenhydramine liquid orally 25mg at 11:46pm.  11:53 itching , redness on L arm and throat improving - feeling sleepy. 11:53 BP 113/80, pulse 88.  offered another dose of diphenydramine; declined due to drowsiness. She insisted on going home to rest- her father came to get her aprox 12:30am.  She has family to keep an eye on her also. Has a migraine, sleepy, tightness in Left arm. I advised seeking emergency treatment if symptoms get worse and to update the pharmacy after she is feeling better. I will also follow up with her as discussed.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Pharyngeal oedema
Clinical narrative: Swelling of throat. No difficulties breathing.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Pruritis at injection site followed by 4 cm significant erythema with large vesicles over much of the surface.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient reported "bumps" on the right side of his face that he did not think were there earlier that morning.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Very sore and swollen Axilla on same side as Deltoid IM injection.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Information has been received from a physician via a company representative referring to a 65 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were unknown. It was also reported that the patient received PREVNAR 13 in approximately September 2015 (reported as one year ago). On an unknown date, the patient was administered PNEUMOVAX 23 (lot#, expiration date and dose were unknown) intramuscularly. On an unknown date, the patient experienced local injection site reactions including injection site pain, swelling and fever. There patient had sought for medical attention and unspecified treatment was given for the events. The symptoms resolved after approximately one week of receiving PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and route were not reported), lot # L032391 and expiry date: 26-AUG-2017. No adverse events were reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot # M022531, expiration date: 23-FEB-2018) (dose and route of administration were not reported). There was no adverse effect reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Amnesia, Anxiety, Arthralgia, Back pain, Constipation
Clinical narrative: Pt also states he had 2 or 3 anthrax vaccinations during this time reports he developed multiple symptoms including rashes in the groin area. He states he sought medical evaluation and was told it was chafing and was benign. He also gradually developed muscle and joint pain in the hands, feet and knees, and low back. Additionally he experienced chronic fatigue, night sweats, difficulty concentrating, short term memory loss, alternate constipation/diarrhea, and anxiety. Groin rashes were later diagnosed as psoriasis and joint pain developed into psoriatic arthritis. Disturbance, sleep NOS.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Diarrhoea, Disturbance in attention, Fatigue, Myalgia, Night sweats
Clinical narrative: Pt also states he had 2 or 3 anthrax vaccinations during this time reports he developed multiple symptoms including rashes in the groin area. He states he sought medical evaluation and was told it was chafing and was benign. He also gradually developed muscle and joint pain in the hands, feet and knees, and low back. Additionally he experienced chronic fatigue, night sweats, difficulty concentrating, short term memory loss, alternate constipation/diarrhea, and anxiety. Groin rashes were later diagnosed as psoriasis and joint pain developed into psoriatic arthritis. Disturbance, sleep NOS.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain in extremity, Psoriasis, Psoriatic arthropathy, Rash, Skin abrasion
Clinical narrative: Pt also states he had 2 or 3 anthrax vaccinations during this time reports he developed multiple symptoms including rashes in the groin area. He states he sought medical evaluation and was told it was chafing and was benign. He also gradually developed muscle and joint pain in the hands, feet and knees, and low back. Additionally he experienced chronic fatigue, night sweats, difficulty concentrating, short term memory loss, alternate constipation/diarrhea, and anxiety. Groin rashes were later diagnosed as psoriasis and joint pain developed into psoriatic arthritis. Disturbance, sleep NOS.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Sleep disorder
Clinical narrative: Pt also states he had 2 or 3 anthrax vaccinations during this time reports he developed multiple symptoms including rashes in the groin area. He states he sought medical evaluation and was told it was chafing and was benign. He also gradually developed muscle and joint pain in the hands, feet and knees, and low back. Additionally he experienced chronic fatigue, night sweats, difficulty concentrating, short term memory loss, alternate constipation/diarrhea, and anxiety. Groin rashes were later diagnosed as psoriasis and joint pain developed into psoriatic arthritis. Disturbance, sleep NOS.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb mass, Pruritus, Septic rash
Clinical narrative: This spontaneous report was received from a 51 year old female patient, who was reporting on herself. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date in July 2015, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (site of administration, dose, lot number and expiration date were not reported). On an unknown date in 2015 (reported as the next day), the patient "had a reaction". She stated that her arm became itchy and red, which later (on an unspecified date in 2015) changed to a large itchy lump that made her arm look as though she had "an extra muscle in her arm". A few days later (on an unspecified date in 2015), the patient called and visited her physician, who stated that she had a "septic reaction" to the ZOSTAVAX injection. The physician treated the patient with unspecified antibiotics and "her arm cleared up in a few days". The outcome of the event was reported as recovered on an unknown date in approximately 2015. The reporter considered "septic reaction" to be related to vaccination with ZOSTAVAX. Upon internal review, "septic reaction" to the ZOSTAVAX injection was determined 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 as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot# L040054, expiration date: 26-DEC-2017) (dose and route of administration were not reported). There was no adverse effect reported. This is one of two reports from the same reporter. 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 regarding unknown patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown dates, the unknown patients were vaccinated with improperly stored (incorrect product storage) doses of GARDASIL 9 (lot # L043213 and expiry date 31-AUG-2017) (lot # M004116 and expiry date 31-OCT-2017) (dose, frequency and route were unknown). No concomitant medications were reported. On unspecified dates the vaccine was exposed to temperature excursions of 1 Celsius for 176 hours and 9 Celsius for 32 hours. There were no prior excursions and a data logger was not used. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician regarding a patient of unknown demographics. There was no information about concurrent condition and historical medications. On 22-SEP-2016, the patient was vaccinated with ZOSTAVAX lot # L021609/expiration date-10-SEP-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL 9, (dosing regimen and frequency unknown) (lot number and expiry date unknown) intramuscularly. No concomitant medications were reported. On an unknown date the patient fainted after receiving the shot for GARDASIL 9. It was reported that the patient sought medical attention and was at the physician's already. It was unknown if the patient received  treatment for the event. The outcome of syncope was reported as recovered. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant via a filed employee refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patient was vaccinated with two doses of GARDISAL intramuscularly in the right arm (dose, lot number and expiration date were not reported). On an unknown date and unspecified time after vaccination, a "bump" appeared at the injection site, which appeared after she took a shower. No treatment was given for the event. The patient sought medical attention by office visit. The outcome of the event was not reported. Product quality complaint was not involved. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Information has been received from a physician via a company representative concerning a female patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date in July 2016 (reported as "two months ago"), the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date and dose were unknown), intramuscularly. On an unknown date in 2016 (reported as "eleven days after the GARDASIL 9 was administered"), the patient experienced a headache which was turned out to be a chronic headache. Because the patient was still experiencing the chronic headache, the patient's mother explained that the patient would not receive the second or third dose of GARDASIL 9 series. At the time of reporting, the patient did not recovered and was still experiencing the chronic headache. The patient did not seek medical attention. No product quality complaint (PQC) was involved. The causal relationship between the event and GARDASIL 9 was not provided. Additional information has been requested.
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Abdominal discomfort, Dizziness, Malaise, Vomiting
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 15 year old male patient. The patient had no pertinent medical history but was allergic to dairy, pistachios and penicillin. On 20-SEP-2016 the patient was vaccinated with the first dose of GARDASIL or GARDASIL 9 (unspecified Merck HPV vaccine, lot number provided) via the intramuscular route. On the same day, patient was also administered and unspecified flu shot (also reported as concomitant medication). The patient had a full physical that day. He was fine in the office and went home. He ate 'takeout food'  for dinner and went to bed. When he awoke on 21-SEP-2016, he told his mother that he felt dizzy and his stomach felt horrible (abdominal discomfort). The patient threw up and then went to bed to rest. He woke up again sometime later but he was still feeling sick and dizzy. Patient received treatment for the events. No laboratory tests were performed. Patient had not recovered from the events. Patient received treatment for the events. No laboratory tests were performed. Patient had not recovered from the events. Causality assessment was not provided. Additional information is not expected since the physician cannot be contacted.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pain
Clinical narrative: MOTHER REPORTS WHEN CHILD WOKE ON 8/20 HER LEFT ARM WAS SWOLLEN AT THE INJECTION SITE, PAINFUL TO MOVE, HOT TO TOUCH. SYMPTOMS LASTED 4 DAYS.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: She woke up with pain, swelling, and warmth at the injection site. She also had an elevated heart rate. After visiting a provider, she was given ice and ibuprofen.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy skin. hives.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L032396, expiry date 26-AUG-2016, 1 dose subcutaneously. No adverse effect was reported. Therapy with VARIVAX was continued. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender, whose medical history, concurrent conditions and concomitant medications were not known. On an unknown date, the patients may have been vaccinated with VARIVAX (lot number L000456, expiry date 06-JAN-2017) that was improperly stored (temperature 8.4F for 36 hours (doses may have been given). There were no previous exposures and no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On 23-SEP-2016, the patient was vaccinated with (Oka/Merck) PROQUAD lot # L047305, expiry date: 23-MAY-2017 and (Oka/Merck) VARIVAX, lot # L000455, expiry date: 06-JAN-2017 (dose and route was not reported for both vaccines) during the same office visit (Inappropriate schedule of drug administration). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient's concurrent conditions included an allergy to SEPTRA. Her medical history and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with the dose of ZOSTAVAX (lot # M011665, expiration date 17-MAY-2017, 0.65 ml, once, subcutaneously). On 20-SEP-2016, the patient developed redness and pain at the injection site that was the size of a dime. The pharmacist reported that when the patient came back to the pharmacy on 21-SEP-2016, the redness at the injection site had increased to the size of a quarter and a hard lump developed under the skin at the injection site. No treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M024702, expiration date 18-MAY-2018; lot # L044524, expiration date 09-NOV-2017, dose not reported) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 which had lot # K007825 with expiry date 13-JAN-2016 (dose and route not reported). No adverse effects reported. No further information provided. Additional information is not expected as the reporter did wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 15-SEP-2016, the patient was vaccinated an expired dose of ZOSTAVAX (dose and route unknown, lot # L021609, expiration date 10-SEP-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot number M014301, expiration date: 22-SEP-2017 and lot number M001151, expiration date: 05-JUL-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -11 degrees Celsius for 352 hours and 51 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (linked with MARRS# WAES1609USA011329). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin hyperpigmentation
Clinical narrative: Information has been received from a retired physician referring to himself, a male patient of unknown age. There was no concomitant medication, medical history or drug reactions/allergies. On an unspecified date in 2006, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot #, expiration date and route were unknown; 0.65 ml/1 dose). On an unspecified date in May 2016, the patient developed a rash on his left thigh, between his knee and groin. On an unspecified date in 2016, he saw an unspecified dermatologist, who diagnosed the rash as shingles. Treatment was given for the event but no lab diagnostics studies were performed. It was reported that the rash was painful for 1 week, but lasted for 6 weeks. At the reporting time (reported as "now"), the rash had resolved, but the patient continued to have areas of hyperpigmentation where the rash was provided. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (2 doses) of ROTATEQ (lot# L037574 with an expiry date of 01-JUL-2017) (dosing details not known). The administered doses experienced a temperature excursion of 0.5 degree Celsius for 1 hour and 32 minutes. The vaccine underwent previous temperature excursions of 1 degree Celsius for 7 hours and 34 minutes. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.
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. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of ZOSTAVAX (lot # M019646, expiration date 18-JUL-2017, subcutaneously; dose was not reported). No adverse effects were reported. The vaccine was stored in 10F for 48 hours and on the other date, in 10F for 24 hours. The call was made because of the data logger. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema multiforme, Injection site reaction, Pallor, Rash papular, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician and a company representative refers to a 3 year old male patient. The patient's medical history included otitis in approximately 2015 (reported as about 1.5 years ago) treated with amoxicillin. One week later, the patient was given TAMIFLU and he broke out into erythema multiforme on an unknown date. It was unknown which medication caused erythema multiforme. There were no concomitant medications. On 30-AUG-2016, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). On the same date, he experienced an injection site reaction which resolved on an unknown date in 2016 (reported as shortly after). On 16-SEP-2016, the patient began to experience red papules on his torso, belly and back, with no fever. The physician reported that on 20-SEP-2016, the patient came to the office and that the papules progressed up the patient's torso, legs, private area and in his ears, like classic symptoms of chicken pox. The patient was sent home without treatment at this point. The reporter also noted that on 22-SEP-2016, the patient's mother sent pictures of the patient's rash to the physician and she felt as if the rash looked more like erythema multiforme (since an unspecified date in September 2016), described as large, red papules with pale centers and she might treat it with steroids. At the time of this report, no treatment was given for the adverse events and no lab diagnostics studies were performed. The outcome of erythema multiforme and rash varicelliform was reported as not recovered at the time of this report. The relatedness between the adverse events and VARIVAX was not provided. Upon internal review the adverse event of erythema multiforme was considered to be medically significant. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a 64 year old female patient (also a nurse) referring to herself. The patient had no medical history and was allergic to ibuprofen. Concomitant medication included blood pressure medicine. On 22-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot #, expiration date and dose were not reported, subcutaneous). On 23-AUG-2016, the patient experienced a reaction described as "a slight pink area at the injection site". The patient didn't sought medical attention and no treatment was given for the event. No lab diagnostics studies were performed. On 25-AUG-2016, the patient recovered. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This solicited report has been received from a 27 year old female patient regarding herself, while she was part of a Market Research. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23. Other suspect therapies included influenza virus vaccine (unspecified). The patient reported that when she was "younger", she would get very sick after vaccination with PNEUMOVAX 23 and influenza virus vaccine (unspecified). The outcome of the event is unknown. Causality of the event with the suspect therapies was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician regarding of unknown demographics. There was no information about concurrent condition and historical medication. On 22-SEP-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # L007720/ expiration date- 08-JUL-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information is not expected as reporter does not wants to get contacted.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Novartis) (Reference number: PHEH2016US015660) on 16-Sep-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergies to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Blindness
Clinical narrative: Initial unsolicited report received from a consumer via social media and from other company (Merck) on 19 September 2016. This case involves female patient (age not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, route and site of administration not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination patient experienced severe reactions (not specified) and as result of reactions patient became blind. Lab data and corrective treatment was not reported. Patient was not recovered from event. Upon internal review the case was considered as serious because of important medical event blind. List of documents held by sender: none. Sender's Comments: This is a poorly document case. Patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE following which patient was blind. Time to onset is unknown, detail medical history, any recent CNS infection, ophthalmological disorder are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Sex: U
Vaccine: MEN
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a healthcare professional (pharmacy intern) on 16 September 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Menomune (dose, batch number, expiry date, site and route of administration of were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced adverse event (unspecified) to vaccine. Laboratory investigations and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 0.8
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 month old patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 06-SEP-2016, the patient was inadvertently vaccinated with PROQUAD (dose and route unknown) from lot # M006101 with expiry date of 01-AUG-2017 at the age of 9 months. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and body aches within 3 hours of flu vaccination.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site warmth, Peripheral swelling, X-ray limb
Clinical narrative: (L) arm swelling, pain, elevated temperature at site for greater than 2 weeks after injection.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Local reaction to thigh-large.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Headache, Nausea, Pallor
Clinical narrative: About 1 hour after receiving TRUMENBA started c/o headache, nausea, SOB, pale. Mom offered ibuprofen, fluids, rest. Patient fell asleep-awoke the next morning feeling ok and went to school.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Information has been received from a 60 year old female consumer via a company representative concerning herself. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On the patient's 60th birthday (date unspecified), the patient was vaccinated a dose of ZOSTAVAX (lot #, expiration date, dose and route were unknown). Then the patient developed a pretty bad reaction in her arm, which included swelling and redness which lasted for weeks (date unspecified). At the time of reporting, the outcome of the events was not provided. No product quality complaint (PQC) was involved. The causal relationship between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # M013377, expiration date 25-MAY-2017, dose and route unknown) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 30 year old patient of unknown gender. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was inadvertently vaccinated with a dose of PROQUAD (lot # M006102, expiry date: 01-AUG-2018). Nurse reported that it was outside the recommendations per prescribing information. No adverse effects were reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: ANTH, FLU4, TYP
Symptoms: Headache, Hypertension
Clinical narrative: Headache and Hypertension.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Fever, muscle aches, stiff neck, chills,swelling and redness at injection site, lost use of arm.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, stiff neck, chills,swelling and redness at injection site, lost use of arm.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large, red, swollen bump at injection site.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Roughly 6-8 hours after receiving the PNEUMOVAX vaccine, she experience swelling described as the size of a baseball where she received the injection. She also reports the area is warm to the touch and very painful, and if arm is moved, she experiences pain down her arm and into her chest. She has been taking ibuprofen to help manage these symptoms.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Roughly 6-8 hours after receiving the PNEUMOVAX vaccine, she experience swelling described as the size of a baseball where she received the injection. She also reports the area is warm to the touch and very painful, and if arm is moved, she experiences pain down her arm and into her chest. She has been taking ibuprofen to help manage these symptoms.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Flank pain, Limb discomfort, Myalgia
Clinical narrative: Patient had a PREVNAR 13 vaccination done in August 2015. Ever since that injection she has had muscle aches, weakness and radiating pain on the left side. She was concerned about her heart so she came in and saw Dr. at the end of August in 2015. Dr.did have her stop her Crestor which gave partial symptom relief. Unfortunately, she still has persistent discomfort in that arm which she directly attributes to the vaccine. She is not interested in resuming Crestor at this time as she definitely feels that it makes things worse.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Injection site pain
Clinical narrative: Patient had a PREVNAR 13 vaccination done in August 2015. Ever since that injection she has had muscle aches, weakness and radiating pain on the left side. She was concerned about her heart so she came in and saw Dr. at the end of August in 2015. Dr.did have her stop her Crestor which gave partial symptom relief. Unfortunately, she still has persistent discomfort in that arm which she directly attributes to the vaccine. She is not interested in resuming Crestor at this time as she definitely feels that it makes things worse.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information was concurrent condition and historical medications. On 21-SEP-2017, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902/ expiration date- 18-JUL-2017. Temperature was 6.7 F(Fahrenheit), temperature was 30 minutes and call was not because of the data logger. Previous temperature excursion was 12 F for 2 hours. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PCQ (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
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. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of ZOSTAVAX (lot # M019646, expiration date 18-JUL-2017, subcutaneously; dose was not reported). No adverse effects were reported. The vaccine was stored in 10F for 48 hours and on the another date, in 10F for 24 hours. The call was made because of the data logger. This is one of several reports received from the same source. Additional information has been requested.