chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hyperhidrosis, Joint contracture, Mydriasis, Pallor, Unresponsive to stimuli
Clinical narrative: Pt. had Varicella Vaccine & Hep. B Vaccine @ 0910am. While attempting to sit in waiting room she stated she felt funny like she was going to pass out. She went forward & hit her L Forehead on the wall. Was then assisted into chair. Rescue called, At that time she was disoriented, weak, pale & diaphoretic. She was able to answer what her name is. She then slumped over, became unresponsive for a few seconds...increased diaphoresis, noted that hands became clenched. Smelling Salts administered, ice pack applied to back of neck. Pt became responsive, able to answer questions appropriately. Pupils dilated to approx. 14mm. VS P-60, RR-12, BP-101/49, O2 Sat 97%. Rescue arrived, VSS,PERRLA @ 6mm, she stated she felt better and initially declined transport to ED. While waiting for ride...she stated that she was feeling worse & that her vision was "Wavy/Blurry" similar to an "Aura" she has had in the past with Migraines. Pupils again dilated to approx. 10mm. Denied headache & nausea. Rescue again called & she was transported to ED.
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Pt. had Varicella Vaccine & Hep. B Vaccine @ 0910am. While attempting to sit in waiting room she stated she felt funny like she was going to pass out. She went forward & hit her L Forehead on the wall. Was then assisted into chair. Rescue called, At that time she was disoriented, weak, pale & diaphoretic. She was able to answer what her name is. She then slumped over, became unresponsive for a few seconds...increased diaphoresis, noted that hands became clenched. Smelling Salts administered, ice pack applied to back of neck. Pt became responsive, able to answer questions appropriately. Pupils dilated to approx. 14mm. VS P-60, RR-12, BP-101/49, O2 Sat 97%. Rescue arrived, VSS,PERRLA @ 6mm, she stated she felt better and initially declined transport to ED. While waiting for ride...she stated that she was feeling worse & that her vision was "Wavy/Blurry" similar to an "Aura" she has had in the past with Migraines. Pupils again dilated to approx. 10mm. Denied headache & nausea. Rescue again called & she was transported to ED.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient has a seizure, was evaluated in our office by two Pediatricians who advised the step to take to make sure patient was ok.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Feeling abnormal, Injection site erythema, Pyrexia, Vaccination site warmth
Clinical narrative: Pt had fever, fatigue, site where vaccine admin. was red and warm to touch.  Pt felt bad in general.  Pt called concerned and was informed of how to treat reaction.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Death
Clinical narrative: Patient was found unresponsive.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling to site with redness noted and fever. At time of visit temperature was 99.3. Provider reassured mom that this was a normal reaction to vaccine. Given TYLENOL and Ibuprofen for fever or discomfort.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Induration, Injection site pain, Muscular weakness, Rash pruritic
Clinical narrative: Diffuse pruritic indurations on arms neck and pain and weakness on injection arm.
Age: 54.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Injection site joint pain, Injection site reaction, Joint crepitation
Clinical narrative: (L) shoulder joint sore; pain in joint "clicks" at times; has gotten better some.
Age: 54.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Injection site joint pain, Joint crepitation
Clinical narrative: (L) shoulder joint sore; pain in joint "clicks" at times; has gotten better some.
Age: 54.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: (L) shoulder joint sore; pain in joint "clicks" at times; has gotten better some.
Age: 24.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, TDAP
Symptoms: Computerised tomogram, Head injury, Syncope
Clinical narrative: Patient fainted and hit head. Patient also gave blood just prior to getting immunizations.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Erythema, Injection site swelling, Myalgia
Clinical narrative: Muscle soreness when lifting arm (3 days) Diarrhea/chills (5/22/2016)part of the day -treated with one dose of Pepto Bismol Itching 5/23/2016 - present Redness/rash about 6 inch circle noticed today 5/25/2016 - treated with Cortisone cream for itch.  Contacted Dr. for advice.  Awaiting returned call. No fever or other reactions other than a bump at the injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Muscle soreness when lifting arm (3 days) Diarrhea/chills (5/22/2016)part of the day -treated with one dose of Pepto Bismol Itching 5/23/2016 - present Redness/rash about 6 inch circle noticed today 5/25/2016 - treated with Cortisone cream for itch.  Contacted Dr. for advice.  Awaiting returned call. No fever or other reactions other than a bump at the injection site.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site mass, Injection site swelling, Joint range of motion decreased
Clinical narrative: Injected very high on the shoulder, missing the muscle. Large Lump and swelling at the injection site, worsening bruising over the following week, worsening pain and limited range in motion in the shoulder over the month following the vaccination.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Injected very high on the shoulder, missing the muscle. Large Lump and swelling at the injection site, worsening bruising over the following week, worsening pain and limited range in motion in the shoulder over the month following the vaccination.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, swelling and large area of erythema redness. Patient called on call doctor after hours with complaint.
Age: 67.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Received PCV-13 and 3 days later developed redness, swelling, and itching on top left shoulder and upper left arm. Doctor prescribed ibuprofen 800 mg every 8 hours for pain, swelling, and redness to use for 3 days, BENADRYL 50 mg every 6 hours as needed for itching. Patient was seen by doctor on 5/23/16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in jaw, Paraesthesia
Clinical narrative: Pt. given HPV and MCV4 on 9/17/12 - site where HPV given pt. had radiating jaw pain and facial tingling. Pt had 2nd HPV alone on 11/19/12 and had the same reaction.  Pt in for PE today and offered 3rd HPV but declined and told Dr. this info.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information received on 11MAY2016 from GlaxoSmithKline. The female subject was enrolled in a blinded study sponsored by GlaxoSmithKline. An approximately 28 year old female experienced drug exposure during pregnancy and a subsequent spontaneous abortion following the administration of BioThrax or BioThrax and study drug raxibacumab plus diphenhydramine which was considered medically significant. It was reported that the subject's last menstrual period was 23AUG2015 with an estimated date of delivery calculated as 29MAY2016. On 03SEP2015 and 17SEP2015 (also reported as 27SEP2015), she received BioThrax or BioThrax and study drug raxibacumab plus diphenhydramine (blind not broken). The subject received BioThrax or BioThrax and raxibacumab beginning at week 1 of the gestational period. The subject reported that she had been emotionally stressed caring for other small children, lack of sleep and financial burdens but no reports of trauma or confounding factors.  Subject stated that her birth control was oral norethindone 0.35mg qd, first dose estimated AUG2015. In October 2015, a urine pregnancy test was performed to confirm pregnancy. On 25NOV2015, 83 days after the first dose of BioThrax or BioThrax and raxibacumab, she experienced spontaneous abortion at 13 weeks gestation (also reported as 10 weeks and 5 days of gestation). The outcome of the spontaneous abortion was considered recovered/resolved on 25NOV2015.  The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. Treatments: none reported. Concurrent medical conditions included: stress, fatigue, and financial burdens. Concomitant medications included: prenatal vitamins and oral contraceptive norethindrone. Relevant laboratory/diagnostics: urine pregnancy test to confirm pregnancy (October 2015). The investigator considered that there was no reasonable possibility that the spontaneous abortion may have been caused by BioThrax or BioThrax and Raxibacumab plus diphenhydramine. No additional information is expected. World Wide #: US-GLAXOSMITHKLINE-US2015GSK144306.
Age: 16.0
Sex: F
Vaccine: FLU3, FLUX(H1N1), MNQ, TDAP, VARCEL
Symptoms: Antibody test negative, Herpes zoster
Clinical narrative: Initial unsolicited report received from a nurse via other company (Merck) on 09-May-2016. This case involves a 16-year-old female patient who was vaccinated with a dose of Fluzone, a dose of MENACTRA, a dose of H1N1 vaccine, a dose of BOOSTRIX (other manufacturer, batch number, expiry date, route and site of administration: not reported for all the vaccines) and a second dose of Varivax (Other manufacturer, batch number: 0675AA, expiry date, route and site of administration: not reported) on 12-Oct-2011. Patient's pertinent medical history included hirsutism. Patients drug reactions/ allergies was reported as none. Concomitant medications were not reported. The patient was previously vaccinated with Varivax on 13-Sep-2000 (details not reported). On an unspecified date, following the vaccination, the patients had shingles three times. On an unspecified date, the patient went to see a physician. On 28-Mar-2016, blood titer was performed and the patient was found to be negative for varicella antibodies. The patients received corrective treatment with Valtrex for shingles outbreak. On an unspecified date, the patients recovered from each shingles outbreak. (It was also reported that the "patient's present status was unspecified"). List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Right upper arm with pain, tenderness, swelling, having nausea.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Muscular weakness, Myalgia, Neuralgia, Pyrexia, Urinary retention
Clinical narrative: Patient developed fever and myalgias 2 days after 3rd shot in rabies series. The patients symptoms progressed to bilateral ascending nerve pain and weakness in the lower extremities that progressed to the upper extremities, back, shoulders and neck over the last 4 weeks. These symptoms are starting to resolve. The patient was treated on 12 May 16 with oral prednisone and naproxen for the pain. Patient is also having urinary retention that started 24 May 16 but it is unknown at this time if this is related.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Arthralgia, Chills, Joint swelling, Pain in extremity, Peripheral coldness
Clinical narrative: Pruritic rash, fever/chills, joint pain wrists, finger and knees. Swollen face, fingers and feet/ankles. Cold, purple toes & fingers. He was diagnosed with serum sickness.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Peripheral swelling, Protein total decreased, Proteinuria, Pyrexia, Rash pruritic
Clinical narrative: Pruritic rash, fever/chills, joint pain wrists, finger and knees. Swollen face, fingers and feet/ankles. Cold, purple toes & fingers. He was diagnosed with serum sickness.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Serum sickness, Skin discolouration, Swelling face
Clinical narrative: Pruritic rash, fever/chills, joint pain wrists, finger and knees. Swollen face, fingers and feet/ankles. Cold, purple toes & fingers. He was diagnosed with serum sickness.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Arthralgia, Peripheral swelling, Protein total decreased, Pyrexia, Rash generalised
Clinical narrative: Pruritic rash, fever/chills, joint pain wrists, finger and knees. Swollen face, fingers and feet/ankles. Cold, purple toes & fingers. He was diagnosed with serum sickness.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Urticaria
Clinical narrative: Pruritic rash, fever/chills, joint pain wrists, finger and knees. Swollen face, fingers and feet/ankles. Cold, purple toes & fingers. He was diagnosed with serum sickness.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pyrexia, Skin warm
Clinical narrative: Warm sensation in left arm, developed sore throat and fever in evening. Symptoms subsided by next day.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Bone pain, Joint range of motion decreased, Muscular weakness, Pain, Tenderness
Clinical narrative: Hurts to abduct left arm and move it over her head.  Feels like it may be weak.  The ache comes and goes.  She has taken advil as needed and it does help. She exhibits decreased range of motion, tenderness and bony tenderness. She exhibits no swelling, no effusion, no crepitus, and no tingling.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: X-ray limb
Clinical narrative: Hurts to abduct left arm and move it over her head.  Feels like it may be weak.  The ache comes and goes.  She has taken advil as needed and it does help. She exhibits decreased range of motion, tenderness and bony tenderness. She exhibits no swelling, no effusion, no crepitus, and no tingling.
Age: 4.0
Sex: F
Vaccine: DTPIPV, MMRV
Symptoms: Cough, Eye swelling
Clinical narrative: LEFT EYE BEGAN TO SWELL, DEVELOPED COUGH WAS GIVEN epinephrine AND BENADRYL IN OFFICE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient started vomiting and running fever the evening vaccine was administered. Patient developed swelling, redness, warmth, and hard knot at site of injection in left leg.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Patient started vomiting and running fever the evening vaccine was administered. Patient developed swelling, redness, warmth, and hard knot at site of injection in left leg.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Right lower back (L4 dermatome) shingles outbreak - primary occurrence.
Age: 18.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Reported decreased fetal movement following vaccine administration at visit 5/20/16.  Presented on 5/24/16 to L&D and diagnosed with fetal demise.
Age: 18.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal death, Stillbirth
Clinical narrative: Reported decreased fetal movement following vaccine administration at visit 5/20/16.  Presented on 5/24/16 to L&D and diagnosed with fetal demise.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Redness, warmth, and lump (injection site reaction).
Age: 25.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Altered state of consciousness, Dizziness, Fall, Immediate post-injection reaction
Clinical narrative: Immediately after administration of Pneumovax 23, patient stated she felt lightheaded and lowered head to knees. She then slumped briefly and slid to ground, I caught her shoulder to ease her to the floor.  She did not seem to lose consciousness fully and stated she had the same event previously while donating plasma.  She stated it usually passed after 5 minutes.  She refused an ammonia ampule and took a glass of water.  After 10 minutes of observation, she left the pharmacy without a word.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site rash, Injection site swelling, Loss of consciousness
Clinical narrative: Immediately after administration of Pneumovax 23, patient stated she felt lightheaded and lowered head to knees. She then slumped briefly and slid to ground, I caught her shoulder to ease her to the floor.  She did not seem to lose consciousness fully and stated she had the same event previously while donating plasma.  She stated it usually passed after 5 minutes.  She refused an ammonia ampule and took a glass of water.  After 10 minutes of observation, she left the pharmacy without a word.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Mobility decreased, Pain, Pain in extremity, Swelling
Clinical narrative: Immediately after administration of Pneumovax 23, patient stated she felt lightheaded and lowered head to knees. She then slumped briefly and slid to ground, I caught her shoulder to ease her to the floor.  She did not seem to lose consciousness fully and stated she had the same event previously while donating plasma.  She stated it usually passed after 5 minutes.  She refused an ammonia ampule and took a glass of water.  After 10 minutes of observation, she left the pharmacy without a word.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, RVX
Symptoms: Laboratory test, Oropharyngeal pain, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fever, sore throat, red spotted rash all over body.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, myalgia and fever 100.9 degree F.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site reaction, Limb discomfort, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Flu vaccine administered into left shoulder joint - patient heard "gritty squish" upon injection. Within a few days discomfort set in upon certain left arm movements - such as reaching back, reaching up, twisting/turning arm. Symptoms worsened over time - evaluated by orthopedic (2 different). Surgery date: June 7, 2016.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Flu vaccine administered into left shoulder joint - patient heard "gritty squish" upon injection. Within a few days discomfort set in upon certain left arm movements - such as reaching back, reaching up, twisting/turning arm. Symptoms worsened over time - evaluated by orthopedic (2 different). Surgery date: June 7, 2016.
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Information has been received from a healthcare worker via a company representative referring to an adolescent male child of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL 9 (dose, dose number, lot# and expiration date unknown, intramuscular). Concomitant medication was not reported. On unknown dates the patient experienced pain at injection site and radiating numbness down the right arm. The patient called doctor's office. No lab diagnostics studies were performed and no treatment was given for the events. The pain and numbness subsided after one week. Finally, the patient recovered from the events (dates unknown). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age who was enrolled in a market research. When the patient was a child (date unspecified), she was vaccinated with M-M-R (manufacturer unknown) (lot #, dose and route unspecified). On an unknown date the patient experienced hurt like a stink and she stayed with her physician. The outcome of the event was resolved with sequelae. The reporter considered the event to be related to MMR (manufacturer unknown). Additional information is not expected as the reporter was not willing to contact to discuss further.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. On 20-MAY-2016 the patient was vaccinated with an expired dose of VARIVAX (first dose, lot # K006133, expiration date: 29-APR-2016, subcutaneous, dose was unknown) (expired product administered). No adverse effects were reported. This is one of several reports received from the same patient. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Miliaria, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient with high blood pressure and celiac disease. There was no drug allergies. On 17-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) for to prevent Shingles. On 18-MAY-216, following the administration of ZOSTAVAX, the patient developed a fever, chills, a headache and a heat rash. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the outcome of all even was not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an expired dose of PROQUAD (Merck), subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Information has been received from a physician via a company representative referring to a 17 year old female patient with anxiety, hyperandrogenism, Hashimoto's disease and penicillin allergy. The patient's medical history included ovarian cyst. The patient was not pregnant. On 11-APR-2016 the patient was vaccinated with the first dose of GARDASIL 9 (1 shot, intramuscular, lot# and expiration date unknown). Concomitant medication was not reported. On 13-APR-2016, 2 days after vaccination the patient experienced fatigue, headaches, shortness of breath and sore throat. The patient spoke with her pediatrician who recommended her to rest and increase her fluid intake. On unknown dates in 2016 the patient recovered from the events. 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 healthcare worker refers to 8 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 in 2016, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (lot # L005292, expiration date: 17-AUG-2016) (strength, dose, frequency and route of administration were not reported). The PROQUAD (Merck) was stored at -4 Celsius degree for 145 days since January 2016. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. On 18-MAY-2016 the patient was vaccinated with PROQUAD (Merck) (dose and route were unknown, lot #; K022447, expiry date: 13-MAY-2016). No adverse effects were 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 a patient of unknown age and gender. There was no information abut the patient's pertinent medical history, drug reaction or allergies and concomitant therapies provided. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L037574, expiration date 01-JUL-2017). There was no adverse effect reported. The administration dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 75 minutes. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information about the patient's medial history, drug reaction or allergies and concomitant therapies provided. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L037574, expiration date 01-JUL-2017). There was no adverse effect reported. The administered dose of  vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 75 minutes. A data logger was involved. Thee were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse (L.V.N.) who reported that, on multiple unspecified dates, multiple unspecified patients were administered improperly stored ROTATEQ (lot # L020861, expired date 25-JAN-2017, dose and route not reported). No adverse effect was reported. The vaccines were at temperature 33 F for 74 hours. There was no previous temperature excursion. This is one of the several reports with the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68 year old female patient. The patient had no drug reactions or allergies. The patient's pertinent medical history was not reported. On 30-MAR-2016, the patient was vaccinated in the upper arm with ZOSTAVAX (lot # L025001 and expiration date 06-OCT-2016, dose and route of administration were not reported). Concomitant therapy was not reported. On 01-APR-2016, 2 days after receiving ZOSTAVAX, the patient developed rash, pear-shaped pink dots (abut 6-8 in numbers). The rash appeared in the same arm but in the inner, upper left arm. The patient also complained of itching around area with rash. She sought medical attention and went to see the physician, who recommended her BENADRYL as treatment for the events. There were no lab diagnostics studies performed. The pharmacist followed up with the patient in about a week and the patient was all better. The events resolved completely on an unknown date in April 2016. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients received unspecified doses of improperly stored PROQUAD (Merck) (lot # L005297, expiry date 17-AUG-2016; lot# L002421, expiry date 23-JUL-2016; dose, route and dose number in immunization series were unspecified. Excursion details: Temperature/Time frame: 12F/3 hours. There was a previous temperature excursion: 22F/60 minutes. This report was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse (L.V.N.) who reported that, on multiple unspecified dates, multiple unspecified patients were administered improperly stored GARDASIL (lot # K011325, expired date 08-APR-2017, dose and route not reported). No adverse effect was reported. The vaccines were at temperature 33 F for 74 hours. There was no previous temperature excursion. This is one of the several reports with the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. Information regarding concurrent condition, medical history and concomitant therapy was unknown. On 05-MAY-2016 the patient was inadvertently vaccinated with an expired dose of MMR (manufacturer unknown) (V205C) (rHA, lot # K005574, expired date 17-APR-2016, subcutaneous, dose not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse (L.V.N.) who reported that, on multiple unspecified dates, multiple unspecified patients were administered improperly stored LIQUID PEDVAXHIB (lot # K008873, expired date 06-FEB-2017, dose and route not reported). No adverse effect was reported. The vaccines were at temperature 33 F for 74 hours. There was no previous temperature excursion. This is one of the several reports with 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. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L031272, expiration date 19-NOV-2016, route and dosage not specified). No symptoms reported. It was reported that the vaccine was improperly stored at 32 degrees F for 20.5 hours and 15 F for 11 hours. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of MMR II (lot # K020189, expiration date: 11-SEP-2016) (strength, dose, frequency and route of administration were not reported). The temperature of the storage was 49F for 34.5 hours. There was no adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: RAB
Symptoms: Anxiety, Headache, Hypoaesthesia, Product quality issue
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a male patient who received RABAVERT (batch number 584011A, expiry date unknown). This case was assessed with a product complaint. In March 2016, the patient received RABAVERT. In March 2016, less than a month after receiving RABAVERT, the patient experienced headache and numbness of head. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the headache, numbness of head and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the headache and numbness of head to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The patient had a question regarding the RABAVERT Packaging, he received the Rabies vaccine a week or so back and noticed the packaging stated Rabies and not Rabies vaccine. For some reason, probably the magnitude of Rabies, this had bothered him and would like to confirm this for peace of mind. The healthcare nurse was contacted who confirmed that the patient received RABAVERT vaccine and she had provided him with lot number of product and also sent him packaging. She was not sure where they order the vaccine from but she would get with her supervisor to get that information and would call back. She stated that the patient had called there many times concerned about this vaccination and he was a very anxious customer. The patient told them that he was comparing the packaging to packaging of another rabies vaccination that he received years ago. The nurse called back and provided the contact details of the practice pharmacy to find out where they order this vaccine from. The pharmacist was contacted who provided that the details were the vaccine was ordered. She said that none of the RABAVERT cartons said Rabies only, nor they had an image of a bat on any of the packaging. She stated that they do order one other rabies vaccine, Rabies Immune Globulin that goes by the name HyperRAB and also this vaccine do not say Rabies only on the carton and there is no image of a bat on this vaccine either. She stated she was not sure what the patient was looking at.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (lot # L008273, expiration date 11-MAR-2017, dose and route unspecified). No adverse effects were reported. It was reported that the vaccines were stored at 11 F for 3360 hours. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # L039093, expiration date 06-OCT-2017 (dose, route and site of administration were not reported). No adverse effect was reported. The administered dose of VARIVAX underwent temperature excursion at -7.5 degrees Celsius for 12 hours and 30 minutes. There were no previous temperature excursions. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker/practice manager referring to an unspecified number of patients of unknown age and gender because of a "data logger". Between 06-APR-2016 and 19-MAY-2016, the unspecified number of patients received unspecified doses of VARIVAX (dose and route unspecified) (lot # L034372, expired on 08-SEP-2017 and lot # L032391, expired on 29-AUG-2017), which were improperly stored. The temperature of excursion was 11F and the time frame was 15 minutes as reported. There was no previous temperature excursion. No adverse effect was reported. No further information provided. This is one of 2 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients received unspecified doses of improperly stored VARIVAX (lot# L039092, expiry date 06-NOV-2017; lot# K009756, expiry date 09-JUL-2016; dose, route and dose number in immunization series were unspecified). Excursion details: Temperature/Time frame: 12F/3 hours. There was a previous temperature excursion: 22F/60 minutes. This report was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot# and route were unknown). On an unknown date, the patient developed a rash. The patient was seen by the reporting pharmacist on an unknown date. The outcome of the event was unknown. Additional information is not expected because there was no consent for follow up information.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker/practice manager referring to an unspecified number of patients of unknown age and gender. Between 06-APR-2016 and 19-MAY-2016, the unspecified number of patients received unspecified doses of PROQUAD (Merck) (dose and route unspecified) (lot # L041628, expired on 20-APR-2017) immunization series, which were improperly stored. The temperature of excursion was 11F and the time frame was 15 minutes as reported. There was no previous temperature excursion. No adverse effect was reported. No further information provided. This is one of 2 reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an infant female patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. On 18-MAY-2016, the patient was vaccinated with ROTATEQ orally and experienced vomiting "2 minutes later". The outcome of the event was unknown. The reporter did not provide the relatedness of vomiting with ROTATEQ. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: None. Pt was given expired Hep B vaccine. No adverse effects noted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX injection, lot # L012039, expiration date: 07-JUL-2016; lot # L000448, expiration date: 08-MAR-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Doses of ZOSTAVAX were administered following a temperature excursion at 25 degrees Fahrenheit for 15 hours and 20 minutes on an unknown date (also reported as on 01-OCT-2016). There was no previous temperature excursion. 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: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients received unspecified doses of improperly stored ZOSTAVAX (lot# L017165, expiry date 13-AUG-2016; lot# L036823, expiry date 24-DEC-2016; dose and route were unspecified). Excursion details; Temperature/Time frame: 12F/3 hours. There was a previous temperature excursion: 22F/60 minutes. This report was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The pharmacist stated that sterile diluent (manufacturer unknown) that was expired on 15-JAN-2016 (dose, route of administration and lot number were not reported) was used to reconstitute in-date ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported) and the dose was administered to the patient on 16-MAY-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # L036823 (exact dose, route of administration, expiration date and anatomical location were not reported). On an unknown date, the patient developed redness and swelling at the ZOSTAVAX injection site. The patient sought medical attention - was seen by the pharmacist. The patient was instructed to take unspecified antihistamines and use a cold compress on the area as a treatment. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Healthcare Worker referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K010215, expiration date: 05-MAY-2017; lot # L035105, expiration date: 14-MAY-2017; Lot # K011562 expiration date: 08-APR-2017; (dose and route of administration were not reported). Administered doses of vaccines experienced a temperature excursion of 30 degrees Fahrenheit for 66 hours. This information was a result of a data logger. There were no previous excursions reported. There were no adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Decreased appetite, Depression, Malaise, Paraesthesia
Clinical narrative: Pain and tingling in lower stomach and anorexia, depression worsening, malaise, somnolence.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: Pain and tingling in lower stomach and anorexia, depression worsening, malaise, somnolence.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Erythema, 12 cm oval erythema on upper left thigh, non-tender.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Health dept. provided Tdap to rising 6 graders in school setting. Received vaccine (Tdap) rt. arm - walked to nearby desk - Fainted to floor. 3 RN's present.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt was given PREVNAR on 5-23-16. Mother called office on 5-24-16 c/o redness and swelling at site of injection. Advised to give MOTRIN, apply cool compress. Mother called 5-25-16, increased redness. OV scheduled.
Age: 12.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Fatigue, Gait disturbance, Musculoskeletal stiffness, Nervous system disorder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of knee pain in a 12-year-old male patient who received RABAVERT. Concomitant products included RABAVERT and RABAVERT. In July 2015, the patient received the 3rd dose of RABAVERT. In July 2015, less than a month after receiving RABAVERT and less than a year after receiving RABAVERT, the patient experienced knee pain, neurological disorder nos, stiffness, fatigue and walking difficulty. On an unknown date, the outcome of the knee pain, neurological disorder nos, stiffness, fatigue and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the knee pain, neurological disorder nos, stiffness, fatigue and walking difficulty to be related to RABAVERT. Additional details were provided as follows: On 26th June 2015, the patient received the 1st dose of RABAVERT. On 29th June 2015, the patient received the 2nd dose of RABAVERT. In July 2015, the patient received the 3rd dose of RABAVERT (the reporter was unsure but thought he did received it). Approximately 5 to 6 months before 27th January 2016, i.e., in July 2015, the patient experienced bilateral knee pain, struggling with walking, unable to run, difficulty going up and down stairs with using hand rails, stiffness, fatigue and neurological decline. The emergency medical attention was not required. The product information for previous dose of RABAVERT was unknown. The additional information would be available on follow up.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist of unknown age who is also the patient. The patient's medical history and concurrent conditions were not provided. On 16-MAR-2016, the patient was vaccinated with the first dose of VAQTA (dose, route of administration, lot number and expiration date were not reported), and then on 16-MAY-2016 "two months later", the patient received a booster dose of VAQTA. Concomitant or co-suspect therapies were not provided. The reporter stated that this vaccination schedule was outside of the recommendations in VAQTA prescribing information. No adverse effects were reported, no product quality complaint (PQC) was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager referring to a 14 year old female patient. The patients' concurrent condition. medical history and past drug history were unknown. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not provided). On 20-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # L018351; expiration date 11-AUG-2017) (dose and route were not provided). Concomitant therapies were unknown. The primary reporter stated that the second dose of GARDASIL 9 underwent a previously supported temperature excursion. It was unknown if there was any relevant tests performed. At the time of the report, it was unknown if the patient continued with the last dose of GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Tuesday night 5/24/16-developed hives all over body. No resp symptoms or new exposures. Seen 5/25/16-with hives covering body. -given prednisone & BENADRYL.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid with 9cm x 10cm area of erythema, warmth, slight swelling and discomfort to palpation. No streaking.