chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding to unspecified number of patients of unknown age and gender. Patient demographics were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # L018351, expiry date 11-AUG-2017 9 (dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at cumulative minimum temperature of -40.3 degree Fahrenheit for 193 hours. There was no previous temperature excursion performed. This is one of several reports received from same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Patient developed a fever on April 1st that lasted thur April 4th or 5th, she also developed a rash on her stomach and chest area - that cleared up a few days later.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Back pain, Dyspnoea, Muscular weakness, Pain in extremity
Clinical narrative: Mother refers that the patient presented pain and weakness in legs and back and problems or difficulty breathing in the afternoon post vaccination. No medical evaluation till 4/21/16 when the mother notifies that the patient continues with symptoms and it is recommended she is seen by doctor.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Mother refers that the patient presented pain and weakness in legs and back and problems or difficulty breathing in the afternoon post vaccination. No medical evaluation till 4/21/16 when the mother notifies that the patient continues with symptoms and it is recommended she is seen by doctor.
Age: 0.17
Sex: M
Vaccine: HEP, PPV, RV5
Symptoms: Wrong drug administered
Clinical narrative: 2 month old was given PPSV23 instead of PCV13. Doctor ordered PPSV23 in epic, in error, and MA gave it. Date of injection 3/14/16. Error made known on monthly error report 4/14/16. Dr talked to mom, no tx necessary. PCV 13 to be given.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Brain scan normal, Depression, Headache, Pain, Scan normal
Clinical narrative: 3 weeks after HPV shot pt started having severe headaches and has had them daily for past 2 years. Has seen a neurologist sent to hospital but no dx has been made. Now pt diagnosed with depression due to chronic pain. Also has experienced weight loss.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Weight decreased
Clinical narrative: 3 weeks after HPV shot pt started having severe headaches and has had them daily for past 2 years. Has seen a neurologist sent to hospital but no dx has been made. Now pt diagnosed with depression due to chronic pain. Also has experienced weight loss.
Age: 40.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT DESCRIBED HER LEFT UPPER ARM BEING HOT WITH FEVER AND VERY ICHY WITH A BURNING AND STINGING SENSATION WITH SWELLING THE SYMPTOMS HAVE BEEN PROGESSING SINCE THE 27TH OF APRIL.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LEFT DELTOID SWELLING, TENDERNESS, REDNESS EXTENDING DOWN TO ELBOW REGION, WAS TREATED WITH BENADRYL AND ICE.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Today (04/28/16) patient came to the pharmacy to ask to the Pharmacist, what should she apply to her arm where the vaccine was applied on 04/26/16. The injection site is red, itchy, inflamed, since last night (04/27/16). She reported that the night before, she start feeling an itch at the injection site. She applied Vicks in the injection site, scratched the affected area, and her slept the night before laying over the injection site, also she reported that she does not feel pain.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Fatigue, Flushing, Hypersomnia, Lymph node pain
Clinical narrative: Extreme arm pain. Next morning felt fluish at first. As day progressed, fatigue set in. Lymphnodes in throat started to swelll.  Sinuses started to plug. By end of day, extreme fatigue set in. Slept from 6:30 PM until next morning 6:30 AM. Extreme fatigue, coughing up phelgm, sinuses hurt, lymphnodes were tender. 04/28/2016 still  experiencing fatigue, sinuses and lymphnode swelling/discomfort. No arm pain (lasted only two days). Ibuprophen 600 mg, twice per day helped. Symptoms getting better.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pain in extremity, Productive cough, Sinus congestion, Sinus headache
Clinical narrative: Extreme arm pain. Next morning felt fluish at first. As day progressed, fatigue set in. Lymphnodes in throat started to swelll.  Sinuses started to plug. By end of day, extreme fatigue set in. Slept from 6:30 PM until next morning 6:30 AM. Extreme fatigue, coughing up phelgm, sinuses hurt, lymphnodes were tender. 04/28/2016 still  experiencing fatigue, sinuses and lymphnode swelling/discomfort. No arm pain (lasted only two days). Ibuprophen 600 mg, twice per day helped. Symptoms getting better.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Urticaria, Wheezing
Clinical narrative: Vaccine was administered by the Health Department nursing staff at the local high school. Hives and trouble breathing (wheezing) started about an hour after the vaccine was administered. Redness and swelling of the left arm started a few hours after vaccine was administered. Mother was called by the school nurse to come pick up the pt as soon as the hives started. Mother called the pt's allergist at hospital but was not taken to the ER, urgent care, or PCP. Pt was given Zyrtec and Benadryl per mother. Wheezing stopped at about 3 pm. Hives and redness/swelling in left arm are still present.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Hyperaesthesia, Pruritus, Swelling
Clinical narrative: Swelling, redness, itching, headache, very sensitive.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red with induration at injection site (left deltoid).
Age: 1.39
Sex: M
Vaccine: FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Polymerase chain reaction positive, Rash generalised, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Macular, papular, vesicular, itchy generalized rash on 4/01/2016. Reported less than 50 lesions. Dx with varicella on 4/4/2016.
Age: 1.39
Sex: M
Vaccine: FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Rash vesicular, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Macular, papular, vesicular, itchy generalized rash on 4/01/2016. Reported less than 50 lesions. Dx with varicella on 4/4/2016.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site bruising, Injection site erythema, Injection site swelling, Muscular weakness
Clinical narrative: After injection, injection site had redness and swelling. It is getting better, but is still bruised like, sun burn like skin after 20 days of injection. Also, pt feels muscle weakness and is still tired.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Dizziness, Ear, nose and throat examination normal, Hyperbaric oxygen therapy, Nuclear magnetic resonance imaging
Clinical narrative: On January 16, 2016, my left ear suddenly lost the hearing ability with consistent noisy sound and dizzy when I wake up.  When visiting the ENT specialist and examining my left ear, he found nothing wrong at the visible area. After checking my medical history, he considered the cause of this hearing lost was from the Zoster(Shingles) vaccine I was immunized on Nov. 4, 2015. The reasons to consider from Zoster vaccine because: 1). The vaccine is the live virus. 2). This virus only infects the nerves. 3). The relationship between Shingles infection and hearing lost was clear. 4). The symptoms I had were typically like the hearing lost after shingles infection. 5). Under certain circumstances, my body's immune system was weak, and let these viruses easily recovered and infect the nerves controlling the oranges related to hearing and body balance. The ENT specialist gave me large dose of prednisone for two weeks, but nothing changed, then he referred me to another specialist for directly injecting the Dexamethasone to my left ear totally for 6 doses, still useless. After that I received Hyperbaric Oxygen Therapy for total 16 sessions, still no anything improved.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: On January 16, 2016, my left ear suddenly lost the hearing ability with consistent noisy sound and dizzy when I wake up.  When visiting the ENT specialist and examining my left ear, he found nothing wrong at the visible area. After checking my medical history, he considered the cause of this hearing lost was from the Zoster(Shingles) vaccine I was immunized on Nov. 4, 2015. The reasons to consider from Zoster vaccine because: 1). The vaccine is the live virus. 2). This virus only infects the nerves. 3). The relationship between Shingles infection and hearing lost was clear. 4). The symptoms I had were typically like the hearing lost after shingles infection. 5). Under certain circumstances, my body's immune system was weak, and let these viruses easily recovered and infect the nerves controlling the oranges related to hearing and body balance. The ENT specialist gave me large dose of prednisone for two weeks, but nothing changed, then he referred me to another specialist for directly injecting the Dexamethasone to my left ear totally for 6 doses, still useless. After that I received Hyperbaric Oxygen Therapy for total 16 sessions, still no anything improved.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: Patient reports tenderness and redness that started in the evening on 4/25/2016. She came to the pharmacy on 4/27/2016 to report the reaction. At that time, the margins were marked. The red area extended from her shoulder area to just above the inner part of the elbow. I followed-up with the patient on 4/28/2016 via telephone and the patient reports improvement in the redness and it is all confined to the pen marks on her arm.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Patient called from home stating she felt her throat closing up. RPh asked her to go straight to ER and/or if she wanted us to call the ambulance. Patient refused both and RPh recommended that she still go. RPh called patient 2 hours later and still refused to go to the ER but stated she was feeling better. I called the patient on 4/28/16 at 3pm and she states that she feels fine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Decreased appetite, Hyperacusis, Insomnia, Mental impairment
Clinical narrative: Rashes from head to toe, fever, hyper-sensitivity to noise, severe insomnia, severe mental degredation/confusion. Episodes are recurring and last nearly a week long each episode. She just finished her third episode. Slept less than 5 hours in 5 days. No appetite. Complete mental shut down like she is drugged. Terrible.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rashes from head to toe, fever, hyper-sensitivity to noise, severe insomnia, severe mental degredation/confusion. Episodes are recurring and last nearly a week long each episode. She just finished her third episode. Slept less than 5 hours in 5 days. No appetite. Complete mental shut down like she is drugged. Terrible.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Developed rash on R arm, arm red and itches.  Also broke out all over on her back.  Pt used some cream she received from dermatology in past.  Also advised use of Benedryl prn.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 01-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the left arm (dose and route of administration were not reported). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition and medical history were not provided. On unknown dates, the patients were vaccinated with the improperly stored doses of (Merck) VARIVAX (lot # L025207, expiration date on 07-JUL-2017 and lot #: L041207, expiration date on 20-OCT-2017) (dose and anatomical location were not reported). No concomitant medication was reported. The vaccines were stored in a temperature of 9F during 20 minutes. No previous temperature excursion was reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding to unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on their concurrent conditions, medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L029113, expiry date 27-MAR-2017 (dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at cumulative minimum temperature of -40.3 degree Fahrenheit for 193 hours. There was no previous temperature excursion performed. This is one of several reports received from same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Reaction to PROQUAD on left thigh - Red, warm, hurts to walk on leg - decreased appetite.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, HEPA, MMRV, PNC13
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Pt was inadvertently administered a dose of Hep B instead of ACT-HIB along with PEDIARIX.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia
Clinical narrative: Joint pain (wrist and knee) lasting at least 4 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Urticaria
Clinical narrative: Mom noticed hives on pt buttocks 10:00.  By 2:00 they had spread all over body.  Pt was seen and treated with Benadryl in urgent care.  Will follow up with allergist.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Injection site warmth, Local reaction
Clinical narrative: Large local reaction on left thigh. 12.5 x 16 cm wheal. Localized warmth.
Age: 21.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, redness, tenderness and warm.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dysarthria, Headache
Clinical narrative: 3:15 PM CONFUSION AND SLURRING NOTED. HEADACHE PRESENTED. T-98.9, BP-114/78, P-82. 3:40 PM CONFUSION AND SLURRING RESOLVED. HEADACHE STILL PRESENT 8/10 ON PAIN SCALE. 5:00 PM ACETAMINOPHEN 650 MG TAKEN WITH 12 OZ OF GATORADE. 5:45 PM HEADACHE RESOLVED.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: REDNESS NEAR THE SITE OF INJECTION AND LITTLE REDNESS AROUND THE AREA OF REACTION.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site irritation, Injection site mass
Clinical narrative: Started off as red irritated skin at and around the injection site with some crying and progressed to a swollen hard red lump below the injection site with uncontrollable crying due to pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Pain
Clinical narrative: Started off as red irritated skin at and around the injection site with some crying and progressed to a swollen hard red lump below the injection site with uncontrollable crying due to pain.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Dizziness, Nodule
Clinical narrative: Patient stated that she felt a little dizzy after the shot, but often happens with Flu shots. About 2 hours after receiving the shot, she felt severe lower back pain on her left side (shot given in right arm).  Feels like a knot and is sensitive to the touch. Injection site looks fine, no swelling or redness.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Information has been received from a physician via a company representative referring to a male patient of unknown age. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose and lot# were unknown). No concomitant therapy was reported. On an unknown date the patient experienced hearing loss after receiving the ZOSTAVAX vaccine injection. The patient contacted the physician for medical attention and was not hospitalized. At the time of reporting, the outcome of the event was unknown. Causality was not provided. Upon internal review, the event "hearing loss" was considered as medically significant. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding to unspecified number of patients of unknown age and gender. Patient demographics were not provided. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L044707, expiry date 06-OCT-2018 (dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Vaccine was stored at cumulative minimum temperature of -40.3 degree Fahrenheit for 193 hours. There was no previous temperature excursion performed. This is one of the several reports received from the same reporter. 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 registered nurse regarding an unspecified patients of unknown age and genders. The patients' medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (orally, lot # L037924, expiration date 22-JUN-2017). Concomitant medications were not provided. There were no adverse effects reported. Temperature and time were reported as 0 degrees C for 160 hours. Previous temperature excursion was reported as 9C for 10 hours and 30 minutes. This is one of several reports from the same source (MARRS #1604USA017912, 1604USA017913 and 1604USA017914). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 70 year old female patient. The patient did not have concurrent conditions, medical history or drug reactions. On 18-APR-2016, the patient was vaccinated in her left arm with a dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # L033311, expiration date on 01-DEC-2016 (dose number was not provided). The patient did not take concomitant medications. On an unknown date, the patient experienced injection site rash, reported as: "2.5 to 3 inches oval rash on her left arm". NEOSPORIN was given for the adverse event. The outcome of injection site rash was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not provided. The patient received a dose of GARDASIL (confirmed Lot# K008931 and exp. 04-MAR-2017, dose and route unknown) on 26-FEB-2015, the patient received a dose of GARDASIL 9 (confirmed Lot# K026247 and exp. 29-JAN-2017, dose and route unknown) on 09-JUL-2015 and then the patient received another dose of GARDASIL 9 (confirmed Lot# L000610 and exp. 31-JAN-2017, dose and route unknown) on 11-AUG-2015; this was outside the recommendations per the GARDASIL and GARDASIL 9 prescribing information. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibiotic therapy, Antibody test negative
Clinical narrative: Information has been received from a female physician referring to herself. Information about concurrent condition, medical history and concomitant therapy was not reported. In approximately 1996 (reported as about 20 years ago) the patient was vaccinated with 2 doses of VARIVAX (Merck) (lot#, expiration date, dose and route not reported). In July or August of 2015, when she was seen for her annual physical, she had her blood drawn for varicella titers per her doctor's request. The patient stated her doctor felt the titers were inadequate (antibody test negative). At the time of reporting, outcome of antibody test negative was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Patient presented with post varicella vaccine rash. (Has been over 21 days since vaccine).
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age and genders. The patients' medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042257, expiration date 17-AUG-2018; lot # L038501, expiration date 16-AUG-2018; route of administration, anatomical location and dose were not provided). Concomitant medications were not provided. There were no adverse effects reported. Temperature and time were reported as 0 degrees C for 160 hours. Previous temperature excursion was reported as 9C for 10 hours and 30 minutes. This is one of several reports from the same source (MARRS #1604USA017128, 1604USA017913 and 1604USA017914). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L027733 with exp 13-SEP-2017, lot# L048236 with exp 31-MAR-2018, lot# L039660 with exp 04-FEB-2018, dose, frequency and route were not reported). These vaccines were stored in temperature of 34.5 F, some doses had been out of range for 7 days when administered to patients while other doses had been out of range for 30 days when administered to patients (it could not be determined which of the provided lot numbers were out of range for 7 days vs. 30 days). There was no previous temperature excursion. No symptoms were reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Post varicella vaccine rash (Has been 21 days since vaccine.)
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (unknown age and gender). The patients' medical history or concurrent condition were not provided. On unknown dates the patients were vaccinated with improperly stored GARDASIL (batch/lot# K006117, expiration date as 14-JAN-2017, dose and route were unspecified). No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Vaccine administered 7 days ago. Redness and swelling to top half of arm. After 7 day top half of arm was clear and bottom of half arm above elbow is red and swollen and warm to this touch. Doctor visit on May 3, 2016.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age and genders. The patients' medical history or conditions were not provided. The primary reporter stated that the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # L019836, expiration date 24-MAR-2017, dose, route of administration and anatomical location were not provided) possibly administered since approximately 06-APR-2016. Concomitant medications were not provided. There were no adverse effects reported. Temperature and time were reported as 0 degrees C for 160 hours. Previous temperature excursion was reported as 9C for 10 hours and 30 minutes. This is one of several reports from the same source (MARRS # 1604US0178128, 1604USA017912 and 1604USA017913). 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 healthcare worker and refers to an unspecified number of patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unspecified dates in 2016 (reported as starting on or after 28-MAR-2016), unspecified patients were vaccinated with doses of improperly stored GARDASIL 9 (which had a lot # of L048237 and an expiration date of 08-MAY-2017; However, dosage number and route of administration were not reported). Although, no adverse effects were reported. Another batch of GARDASIL 9 (which had a lot # reported as L026602 and an expiration date of 19-OCT-2017) had also been improperly stored and administered on unspecified dates and patients. The vaccines experienced the following temperature excursions: 27.7 F for 42 hours and 45 minutes on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were no identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age and genders. The patients' medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # reported as M00311, expiration date 15-NV-2017, dose, route od administration and anatomical location were not provided). Concomitant medications were not provided. There were no adverse effects reported. Temperature and time were reported as 0 degrees C for 160 hours. Previous temperature excursion was reported as 9C for 10 hours and 30 minutes. This is one of several reports from the same source (MARRS #160USA017128, 1604USA017912, and 1604USA017914). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 08-OCT-2015, the patient was vaccinated with the first dose in the HPV series with GARDASIL (dose, route and lot # not reported) and on 15-DEC-2015, the patient received the second dose with GARDASIL (route and lot# not reported). No adverse effect was reported. 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 Licensed practical nurse refers to a patient of unknown age gender. On 26-MAR-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (Lot number reported as L010465, expiry date: 23-MAR-2016) (expired product administered). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Increased tendency to bruise, Thrombocytopenia
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 14 year old female patient. The patient's concurrent conditions and medical history were not provided. In 2015, the patient was vaccinated with the first dose of GARDASIL intramuscularly (strength, lot number and expiration date were not provided). The patient's second dose of GARDASIL was in 27-MAR-2015. The patient was given unspecified vaccines concomitantly with the GARDASIL vaccine, however the date of administration for these vaccines was unknown. In March 2016, the patient experienced thrombocytopenia and easy bruising. The outcome of thrombocytopenia and increased tendency to bruise was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Asthenia, Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: 3/5/16 Bilateral hands and feet numbness, tongue, lips numbness. Progressed to legs and arm weakness, headaches, neck pain, facial paralysis, abdominal pain, difficultly swallowing, hoarseness. 3/18/16 went to ER was admitted, MRI of brain,  spinal canal, and thoracic, and had a lumbar puncture the next day correlated for Guillain-Barre. Treated with IVIG for 5 days. Nausea & vomiting controlled. Discharged 3/23/16 Symptoms are mild in hands and feet, and abdomen pain. Referred to outpatient physical therapy, speech therapy, and occupation therapy.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia, Paraesthesia oral
Clinical narrative: 3/5/16 Bilateral hands and feet numbness, tongue, lips numbness. Progressed to legs and arm weakness, headaches, neck pain, facial paralysis, abdominal pain, difficultly swallowing, hoarseness. 3/18/16 went to ER was admitted, MRI of brain,  spinal canal, and thoracic, and had a lumbar puncture the next day correlated for Guillain-Barre. Treated with IVIG for 5 days. Nausea & vomiting controlled. Discharged 3/23/16 Symptoms are mild in hands and feet, and abdomen pain. Referred to outpatient physical therapy, speech therapy, and occupation therapy.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Abdominal pain, Blood test, Dysphagia, Dysphonia, Facial paralysis
Clinical narrative: 3/5/16 Bilateral hands and feet numbness, tongue, lips numbness. Progressed to legs and arm weakness, headaches, neck pain, facial paralysis, abdominal pain, difficultly swallowing, hoarseness. 3/18/16 went to ER was admitted, MRI of brain,  spinal canal, and thoracic, and had a lumbar puncture the next day correlated for Guillain-Barre. Treated with IVIG for 5 days. Nausea & vomiting controlled. Discharged 3/23/16 Symptoms are mild in hands and feet, and abdomen pain. Referred to outpatient physical therapy, speech therapy, and occupation therapy.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy
Clinical narrative: 3/5/16 Bilateral hands and feet numbness, tongue, lips numbness. Progressed to legs and arm weakness, headaches, neck pain, facial paralysis, abdominal pain, difficultly swallowing, hoarseness. 3/18/16 went to ER was admitted, MRI of brain,  spinal canal, and thoracic, and had a lumbar puncture the next day correlated for Guillain-Barre. Treated with IVIG for 5 days. Nausea & vomiting controlled. Discharged 3/23/16 Symptoms are mild in hands and feet, and abdomen pain. Referred to outpatient physical therapy, speech therapy, and occupation therapy.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Lumbar puncture abnormal, Muscular weakness, Nausea, Neck pain, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: 3/5/16 Bilateral hands and feet numbness, tongue, lips numbness. Progressed to legs and arm weakness, headaches, neck pain, facial paralysis, abdominal pain, difficultly swallowing, hoarseness. 3/18/16 went to ER was admitted, MRI of brain,  spinal canal, and thoracic, and had a lumbar puncture the next day correlated for Guillain-Barre. Treated with IVIG for 5 days. Nausea & vomiting controlled. Discharged 3/23/16 Symptoms are mild in hands and feet, and abdomen pain. Referred to outpatient physical therapy, speech therapy, and occupation therapy.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Nuclear magnetic resonance imaging thoracic abnormal, Vomiting
Clinical narrative: 3/5/16 Bilateral hands and feet numbness, tongue, lips numbness. Progressed to legs and arm weakness, headaches, neck pain, facial paralysis, abdominal pain, difficultly swallowing, hoarseness. 3/18/16 went to ER was admitted, MRI of brain,  spinal canal, and thoracic, and had a lumbar puncture the next day correlated for Guillain-Barre. Treated with IVIG for 5 days. Nausea & vomiting controlled. Discharged 3/23/16 Symptoms are mild in hands and feet, and abdomen pain. Referred to outpatient physical therapy, speech therapy, and occupation therapy.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local swelling, Nodule, Pruritus, Skin warm
Clinical narrative: Localized injection site reaction (burning, swelling) treated with Benadryl.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Localized injection site reaction (burning, swelling) treated with Benadryl.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dyskinesia, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Felt unwell, developed fever, felt nausea and fatigue. On 4/14/16 Developed severe tic, tilting head side to side, back and forth and to the far right and left as many as 95 times, every 4-5 seconds this tic has continued to the current date of 4/28/16, has shown no signs of reducing but rather has increased in intensity.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Tic
Clinical narrative: Felt unwell, developed fever, felt nausea and fatigue. On 4/14/16 Developed severe tic, tilting head side to side, back and forth and to the far right and left as many as 95 times, every 4-5 seconds this tic has continued to the current date of 4/28/16, has shown no signs of reducing but rather has increased in intensity.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Corneal reflex decreased, Tic
Clinical narrative: Felt unwell, developed fever, felt nausea and fatigue. On 4/14/16 Developed severe tic, tilting head side to side, back and forth and to the far right and left as many as 95 times, every 4-5 seconds this tic has continued to the current date of 4/28/16, has shown no signs of reducing but rather has increased in intensity.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Immediate post-injection reaction, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Immediately following the vaccine and for the next 1-2 days, she was experiencing significant pain at the injection site. Over the night, she began to develop a low grade fever. Around 2 AM, that night, she began vomiting. The vomiting continued for several hours and then gradually began to go away, along with the fever.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Middle insomnia, Neck pain, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 2 December 2015. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number were not reported) intramuscularly in left deltoid on 19 August 2015. The patient's medical history included no known allergies and concomitant medication were not reported. On an unspecified date, the patient's arm was sore, arm pain had since continued and had developed into throbbing pain that radiated to neck and hand. The pain woke her up 6 or 7 times at night. On 2 November 2015, the patient was seen in hospital ER for temperature 101 (unit not provided). The patient was planning to see a neurologist. The patient required ER or doctor visit. Other laboratory investigation and corrective treatment were not reported. The patient had not recovered from events. List of documents held by sender: none. Follow up information received from a consumer on 01 April 2016. It was reported that, patient was vaccinated with FLUZONE HD (batch number: UI428AB, expiration date: 19 March 2016), intramuscularly in the right deltoid (in initial report left deltoid was reported). Illness at the time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Poor quality sleep
Clinical narrative: Initial unsolicited report received from a consumer on 2 December 2015. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number were not reported) intramuscularly in left deltoid on 19 August 2015. The patient's medical history included no known allergies and concomitant medication were not reported. On an unspecified date, the patient's arm was sore, arm pain had since continued and had developed into throbbing pain that radiated to neck and hand. The pain woke her up 6 or 7 times at night. On 2 November 2015, the patient was seen in hospital ER for temperature 101 (unit not provided). The patient was planning to see a neurologist. The patient required ER or doctor visit. Other laboratory investigation and corrective treatment were not reported. The patient had not recovered from events. List of documents held by sender: none. Follow up information received from a consumer on 01 April 2016. It was reported that, patient was vaccinated with FLUZONE HD (batch number: UI428AB, expiration date: 19 March 2016), intramuscularly in the right deltoid (in initial report left deltoid was reported). Illness at the time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none.
Age: 79.0
Sex: M
Vaccine: FLUX, PNC13, PNC13, FLUX, PNC13
Symptoms: Biopsy prostate, Blood cholesterol, Blood pressure increased, Blood triglycerides
Clinical narrative: Initial unsolicited report received from a consumer and a non-healthcare professional on 21 March 2016. This case involves a 79-year-old male patient who was vaccinated with a dose of Flu Shot (dose, route and batch number not reported) (in the top of arm) and first dose of PREVENAR 13 (dose, route and batch number not reported) both in the left arm on 05 October 2015. The patient also received a second dose of PREVENAR 13 in the right arm (in the top of arm) on an unspecified date (November 2015) (10:30 EST). The patient had a medical history of thyroid for about 10 years. Concomitant medications included Levothyroxine 0.05mg one daily in the morning for Thyroid and was taking it since 10 years and Atenolol 25mg once daily for high blood pressure. On an unspecified date, the patient experienced increased blood pressure prior to receive second vaccination of PREVENAR 13. It was reported that when he saw his doctor for the physical where he received the second dose of PREVNAR 13, his blood pressure was good. Lab tests included cholesterol testing, prostate testing, and triglycerides (values not reported). Corrective treatments were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLUX, PNC13, PNC13, FLUX, PNC13
Symptoms: Blood pressure increased
Clinical narrative: Initial unsolicited report received from a consumer and a non-healthcare professional on 21 March 2016. This case involves a 79-year-old male patient who was vaccinated with a dose of Flu Shot (dose, route and batch number not reported) (in the top of arm) and first dose of PREVENAR 13 (dose, route and batch number not reported) both in the left arm on 05 October 2015. The patient also received a second dose of PREVENAR 13 in the right arm (in the top of arm) on an unspecified date (November 2015) (10:30 EST). The patient had a medical history of thyroid for about 10 years. Concomitant medications included Levothyroxine 0.05mg one daily in the morning for Thyroid and was taking it since 10 years and Atenolol 25mg once daily for high blood pressure. On an unspecified date, the patient experienced increased blood pressure prior to receive second vaccination of PREVENAR 13. It was reported that when he saw his doctor for the physical where he received the second dose of PREVNAR 13, his blood pressure was good. Lab tests included cholesterol testing, prostate testing, and triglycerides (values not reported). Corrective treatments were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a non-health care professional on 13 April 2016. This case is linked to case 2016SA074914 and 2016SA074938. This case involves a 72-year-old male patient who was vaccinated with a dose of ADACEL (batch number U5278AA, expiry date 25 February 2018, site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date (in December), following the vaccination patient arm was so sore he couldn't lift it and it was swollen and red. Patient came back in March still complaining of pain where shot was given. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. It was reported that, events was related to quality of injection. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Neck pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 19 April 2016. This case involves 68-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number and site of administration not reported) intramuscularly on an unspecified date in 2014. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions included rheumatoid arthritis (ongoing). Concomitant medications were not reported. On an unspecified date in 2014, four days following the vaccination, the patient's rheumatoid arthritis flared up like never before.The patient had also experienced pain and achiness in her arms, legs and neck. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received methotrexate which she never had before (ongoing) and prednisone received as corrective treatment. On an unspecified date, the patient was recovered from the events. Upon internal review the case was considered as serious because of important medical event rheumatoid arthritis which flared up like never before. List of documents held by sender: none. Sender's Comments: Rheumatoid arthritis is not expected following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset seems to be compatible with a role of the vaccines. The rheumatoid arthritis is not medically confirmed (because case is reported by consumer). The case is poorly documented. Complementary information regarding patient's condition at the time of vaccination, patient's medical history, concomitant treatment, as well as investigation results confirming the diagnosis (ESR, CRP, CBC, rheumatoid factor, antinuclear antibody assay, anti CCP, CT scan, MRI) and exploring alternative etiologies are needed to further assess the case.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (20 MCG-40 MCG-40 MCG-20 MCG/0.5 ML 1 standard package vial of 0.5, dose, frequency and route were not provided). Concomitant medications were not reported. It was reported that, on an unknown date, patient received the GARDASIL and she fainted in the office following vaccination. On an unknown date, several months later, after fainting, the patient was diagnosed with lupus. Physician reported that patient's parents thought that lupus was brought on by GARDASIL. On an unknown date, the patient was sent for further testing to university and unspecified provider from the university reported that the lupus was caused by GARDASIL. It was not confirmed if patient was completed the GARDASIL series or not. The patient did seek the medical attention by visiting the office. The outcome of Systemic lupus erythematosus and syncope was unknown. Causality between the events and suspect therapy was unknown. Upon internal review the event Systemic lupus erythematosus was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 1 or 2 unspecified patients of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route and dose were not reported) (lot # L024255, expiration date: 01-JUL-2017). The (Oka/Merck) VARIVAX was stored in -10 Celsius degrees for 12 hours. There was no previous temperature excursion and the call was because of a data logger. This is one of two reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Injection site pruritus, Pruritus
Clinical narrative: Employee received #2 varicella vaccine to RUE on 4/27/16 at approx 0900. Today, 4/28/16 approx 0900 employee returned to employee health with noted localized inflammation, approx 40mm x 30mm, erythematous. Employee states she itches and also has a small site to (L) medial wrist approx 15mm x 20mm.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On 07-APR-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, injection (lot # reported as K016425 with expiration date 26-MAR-2016; dose, route of administration, anatomical location and albumin status were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. A product quality complaint was not involved. Additional information has been requested.