chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt did not actually have any adverse events to ZOSTAVAX. Pharmacist did not check the state registry to see if pt had been given immunization already. Pt had one in 2015 and again Oct 2016.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Feeling cold, Pain in extremity, Rash macular
Clinical narrative: Patient felt drowsy and had chills, joints were achy and legs achy, began feeling better the next day, Saturday the 24th she developed small red spots on her leg.  Described as small round blotches like a "rash".
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: Patient felt drowsy and had chills, joints were achy and legs achy, began feeling better the next day, Saturday the 24th she developed small red spots on her leg.  Described as small round blotches like a "rash".
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Anal incontinence, Chills, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: PATIENT HAD SEVERE CHILLS, SEVERE MUSCLE PAINS. COULDN'T MOVE LEGS TILL 10/17 AND >101 FEVER AND BOWEL INCONTINENCE.
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgia, headache.  All subsided at 12:15 AM on 09/24/2016.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, general malaise, mild fever.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red circle at injection site. Redness is about 4 inches in diameter and warm to the touch. Patient denied any itching or pain at injection site. No other symptoms noted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site about size of thumb nail.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: First three days arm was just sore; then arm swelled 5-6 inches wide in circle towards elbow-hot red and swollen.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to pharmacy on 10/16/2016 with symptoms of redness, swelling, and warm to touch from shoulder to elbow of vaccinated arm. Patient was referred to PCP to have the reaction checked out.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itch rash at injection site that extend down patients arm. Patient to take oral Benadryl.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Injected limb mobility decreased, Pain
Clinical narrative: Patient describes redness, hardness and pain. She could not lift arm for 2 days. Symptoms have been occuring since administration. Symptoms are getting better.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Patient presented in pharmacy on 10/17/2016 with redness, inflammation, and swelling in left arm, more toward the inside and toward elbow, not as much around the injection site.  Went to dermatologist and was given samples of desoximetasone and patient was taking Benadryl.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Lip oedema, Periorbital oedema, Swelling face
Clinical narrative: Facial redness and swelling; periorbital and lip edema. No itching or dyspnea. Benadryl given.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, fever of skin, diagnosed cellulitis at Dr office. Extended down from patient's immunization site (deltoid) to the elbow area.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: The patient stated that she initially had slight pain at the injection site with no further problems.  The injection site pain had subsided but returned a few days later.  She indicated that the muscle pain has become increasingly more painful and now has problems with fatigue.  She stated that she did not have any swelling, rash or noticeable increase in temperature at the injection site.  She stated that she may want to seek medical attention.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood test, Chest X-ray, Mass
Clinical narrative: Marble-sized lumps near his left collarbone.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Small Rash on arm below injection site.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Patient came in today and said that she had a one in a million reaction to the vaccine given to her on 10/2/16. She said she had a fever, malaise and her lymph nodes swelled for 2 days. She said she went to the doctors and they told her to keep an eye on it and if it lasted more than 2 days they would have to report to the FDA but it only lasted 2 days with no remaining side effects so they did not report.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site reaction
Clinical narrative: Mild localized injection site reaction appearing to be allergic in nature.  Treated with cold compress and Benadryl.
Age: 22.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red, non-raised rash at the injection site a little larger than a quarter and slightly itchy.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Patient states that she had chills for several hours that subsided later in the evening.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: At about 15 seconds after Vaccination was administered the patient collapsed (Fainted) to the floor. Patient woke up within a few seconds without recognition of what happened. No alleged injuries.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: 3x4 inch raised red itchy area.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient complained of 3 wheals/hives that formed on arm and back (1 on arm and 2 on back).
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Reaction to Prevnar 13. Rash, redness and hardness to a large area of the right upper arm.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea
Clinical narrative: Lightheaded, dizzy, mild nausea.
Age: 54.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site reaction
Clinical narrative: Injection site reactions and possible cellulitis.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling at injection site. Patient was feeling fine, no problems breathing, no rash. Rph applied cold compress and the sweeling decreased.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Pyrexia, Skin warm
Clinical narrative: REDNESS, ITCHING, SWELLING, WARM TO TOUCH, MILD FEVERS, TENDERNESS AND PAIN AT INJECTION SITE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: REDNESS, ITCHING, SWELLING, WARM TO TOUCH, MILD FEVERS, TENDERNESS AND PAIN AT INJECTION SITE.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity, Paraesthesia
Clinical narrative: Immediate soreness in arm, that did not go away after 2 weeks. Arm still sore and tingly, plus loss of range of motion. I believe the shot was given too high, near my shoulder bone. I saw my PCP today. He recommended heat and ibuprofen, and if it doesn't resolve by the weekend, we may have to do a bone scan.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bedridden, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: PT SAYS SHE WAS BEDRIDDEN FOR 2.5 WEEKS AFTER ADMINISTRATION OF THE TWO VACCINES FLUZONE HD AND PNEUMOVAX CONCURRENTLY. HEADACHES, FEVER, CHILLS, DIARRHEA, VOMITING, BODY ACHES WITH EXTREME FATIGUE.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: PT SAYS SHE WAS BEDRIDDEN FOR 2.5 WEEKS AFTER ADMINISTRATION OF THE TWO VACCINES FLUZONE HD AND PNEUMOVAX CONCURRENTLY. HEADACHES, FEVER, CHILLS, DIARRHEA, VOMITING, BODY ACHES WITH EXTREME FATIGUE.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Seizure like phenomena
Clinical narrative: Case number PHEH2016US026177, is an initial spontaneous report received from a consumer on 10 Oct 2016. This report refers to a 59-year-old female patient. Past medical history included throat swelling/thickening throat, itching and seizure like phenomena on COMPAZINE. Concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 04 Oct 2016. On 05 Oct 2016, the patient experienced thickening of throat, itching and pre seizure symptoms/ seizure like phenomena. The patient was treated with BENADRYL. The physician gave the patient steroids (unspecified) and PEPCID. It was reported that, patient felt well (reported as on 7th, date unspecified). The patient stated that, he had similar reactions to COMPAZINE. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non-serious by the consumer. The causality of the events was not reported. The case was lost to follow up at initial.
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2016US026076, is an initial spontaneous report received from a consumer on 07 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine(unknown whether seasonal or pandemic, batch number: not reported) at an unknown dose on an unknown date. The patient received lidocaine (manufacturer unknown) for an unknown indication at an unknown dose on an unknown date. The patient also received Thimerosal (manufacturer unknown) for an unknown indication at an unknown dose on an unknown date. The consumer stated that, she had a reaction Thimerosal in the past with a Lidocaine and flu shot. The symptoms was cellulitis. The outcome of the event was unknown. The seriousness and causality of the events was not reported. The seriousness assessment of cellulitis was upgraded based on Novartis Important Medical Events list. The case was lost to follow up at initial.
Sex: M
Vaccine: FLUC3
Symptoms: Injection site reaction, Malaise, Myalgia, Pain, Rhinorrhoea
Clinical narrative: Case PHEH2016US026052, is an initial spontaneous report received from a consumer on 07 Oct 2016. This report refers to a male patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 06 Dec 2015. The patient experienced typical injections site reaction, 3 days later had runny nose followed by body aches and muscle aches. The patient was later diagnosed with thyroid crisis. It was reported that, the patient still felt sick on an unknown date. The outcome of the event thyroid crisis was reported as condition unchanged and for other events it was not reported. The seriousness and causality of the events was not reported. The seriousness assessment of thyroid crisis was upgraded based on the Novartis Important Medical Events list.
Sex: M
Vaccine: FLUC3
Symptoms: Thyrotoxic crisis
Clinical narrative: Case PHEH2016US026052, is an initial spontaneous report received from a consumer on 07 Oct 2016. This report refers to a male patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 06 Dec 2015. The patient experienced typical injections site reaction, 3 days later had runny nose followed by body aches and muscle aches. The patient was later diagnosed with thyroid crisis. It was reported that, the patient still felt sick on an unknown date. The outcome of the event thyroid crisis was reported as condition unchanged and for other events it was not reported. The seriousness and causality of the events was not reported. The seriousness assessment of thyroid crisis was upgraded based on the Novartis Important Medical Events list.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Dyspnoea, Pharyngeal oedema, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 year old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscular (lot number, expiration date, concentration, dose and frequency were not reported). Concomitant therapies included influenza virus vaccine and meningococcal vaccine. On an unknown date, the patient experienced hives, issues breathing/tremendous trouble breathing, his throat was swollen shut and facial swelling, additionally, it was reported that on an unknown date, the patient went to the emergency room and also he was hospitalized for several unspecified hours. Information regarding laboratories or studies were not reported. The reporter considered that dyspnoea and pharyngeal oedema were life threatening. At the time of the report, the outcome of urticaria, pharyngeal oedema, swelling face and dyspnoea was reported as recovered. The causality between GARDASIL 9 and the adverse events was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Dyspnoea, Lip swelling, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 year old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscular (lot number, expiration date, concentration, dose and frequency were not reported). Concomitant therapies included influenza virus vaccine and meningococcal vaccine. On an unknown date, the patient experienced hives, issues breathing/tremendous trouble breathing, his throat was swollen shut and facial swelling, additionally, it was reported that on an unknown date, the patient went to the emergency room and also he was hospitalized for several unspecified hours. Information regarding laboratories or studies were not reported. The reporter considered that dyspnoea and pharyngeal oedema were life threatening. At the time of the report, the outcome of urticaria, pharyngeal oedema, swelling face and dyspnoea was reported as recovered. The causality between GARDASIL 9 and the adverse events was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: By next morning, very sore, area indurated, itchy, hurting. Redness spreading below site. On 10/16 site still painful, itchy, and spreading.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Neck pain
Clinical narrative: Injection site red, warm to touch, very sore and tender even to front and down arm and upward thru neck day after shots. Given antibiotics as preventative. PNEUMOVAX 23 and FLUVIRIN MDV in (L) arm.
Age: 86.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Myalgia, Rash macular
Clinical narrative: Rash developed 2 weeks after receiving vaccine on opposite arm that was injected rash was not itchy, was splotchy and she complained of muscle soreness in that arm.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Hypoaesthesia oral, Injection site erythema, Injection site pain, Injection site swelling, Lip swelling
Clinical narrative: Information has been received from a licensed practical nurse referring to a 15 years old female patient. The patient had no pertinent medical history, drug reactions/allergies nor concomitant medications. On 23-SEP-2016, the patient was vaccinated with her first dose of GARDASIL 9 (0.5 ml, lot # L036301, expiration date 20-DEC-2017) intramuscularly in the left arm. On the same date, the patient received FLUZONE in the right arm. On 25-SEP-2016, the patient experienced pain at the GARDASIL 9 injection site. On 25-SEP-2016, the patient experienced redness and swelling at the GARDASIL 9 injection site, which had not resolved but had not worsened. On 28-SEP-2016, the patient experienced swelling and numbness of the right upper lip, which resolved after 24 hours (29-SEP-2016). No treatment was given for the events. No laboratory test was performed. The outcome of the event pain at the GARDASIL 9 injection site was unknown. The causality between GARDASIL 9 and the events was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Receive BOOSTRIX instead of Influenza vaccine at flu clinic. No problems noted from pt.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Corneal opacity, Ocular hyperaemia
Clinical narrative: Red bloodshot eyes. Diagnosis of ophthalmologist was peripheral subepith opacities. Treatment: Tobramycin Oph. Sol./Prednisolone Acetate Oph. Sol.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Inflammation, Pain in extremity, Pruritus
Clinical narrative: After one day of the vaccination, the patient began feeling the left arm with inflammation, soreness, redness, itching. Also below her left eye was presented inflammation, like a bump with liquid with a lot of itching and inflammation. Pt took ZYRTEC and then BENADRYL and triple antibiotic to the arm. Tinnitus in left ear was also reported.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: After one day of the vaccination, the patient began feeling the left arm with inflammation, soreness, redness, itching. Also below her left eye was presented inflammation, like a bump with liquid with a lot of itching and inflammation. Pt took ZYRTEC and then BENADRYL and triple antibiotic to the arm. Tinnitus in left ear was also reported.
Age: 27.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: After about 10 minutes post vaccination, patient report feeling light-headed. As I laid her on the floor, she fainted but came to after a few seconds. Pt. was pale. Gave OJ to drink. Full recovery.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Dysstasia, Fall
Clinical narrative: Patient states that evening after receiving FLUAD vaccine, she fell on floor and was unable to get up.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Amnesia, Computerised tomogram, Confusional state, Depressed mood, Full blood count normal
Clinical narrative: Pt awoke having lost her memory of the past 3 weeks. Her mother has tried to orient her and remind her of the events since 9/16/16, but pt has no memory. Mom says Pt seems tranquil and sad. Pt says she's confused. Pt's grandmother has been visiting and this morning question and had (and continues to have no memory of the visit).
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Metabolic function test normal, Toxicologic test normal, Urine analysis normal
Clinical narrative: Pt awoke having lost her memory of the past 3 weeks. Her mother has tried to orient her and remind her of the events since 9/16/16, but pt has no memory. Mom says Pt seems tranquil and sad. Pt says she's confused. Pt's grandmother has been visiting and this morning question and had (and continues to have no memory of the visit).
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Flushing, Headache, Pyrexia
Clinical narrative: Chills, fever, headache, flushing BENADRYL 50mg.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Same day fever, vomit and next day diarrhea. ZOFRAN for nausea; Advised good hydration.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram normal, Chills, Computerised tomogram normal, Dizziness, Facial paralysis
Clinical narrative: Few hours after vaccine, developed chills, body aches, fever, dizziness and light headedness x 5 days. Day 6 (10/5/16) - woke up with slight left droop - went to ED.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Pain, Pyrexia
Clinical narrative: Few hours after vaccine, developed chills, body aches, fever, dizziness and light headedness x 5 days. Day 6 (10/5/16) - woke up with slight left droop - went to ED.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Palpitations, Pruritus, Throat irritation
Clinical narrative: 20 minutes after flu shot had itchy ears/throat progressed to throat tightness, palpitations and dizziness.  Redness to face.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: 20 minutes after flu shot had itchy ears/throat progressed to throat tightness, palpitations and dizziness.  Redness to face.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever up to 105.3 the night of getting vaccines no fever the next day.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Patient had redness, pain/itchy/hot to touch for 4 days.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Decreased appetite, Fatigue, Pain
Clinical narrative: Fatigue, ache, pain/joint pain, loss of appetite.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Pt experienced significant chills, headache, joint pain the evening of receiving the vaccine. Self reported a fever of 101 at 3am and took acetaminophen which lessened symptoms. Resolved the following morning completely. 20+ year history of receiving seasonal flu vaccine w/o incident.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Ear infection staphylococcal, Eye infection staphylococcal, Hordeolum, Injection site pain
Clinical narrative: Site of injection site still sore from several wks ago, now other problems on same side of body - Staph ear infection, eye, 2 stys on eye not healing, pain radiating arm down leg on left side, now swollen on calf (arm is worse now over time) Discussed w/Dr. Suggest flu vaccination possibility, not sure if related.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Site of injection site still sore from several wks ago, now other problems on same side of body - Staph ear infection, eye, 2 stys on eye not healing, pain radiating arm down leg on left side, now swollen on calf (arm is worse now over time) Discussed w/Dr. Suggest flu vaccination possibility, not sure if related.
Age: 40.0
Sex: F
Vaccine: FLU4, HEPAB, TYP
Symptoms: Wrong drug administered
Clinical narrative: TWINRIX given in error. Client had 3 doses of Hep B prior to visit on 10/13/16. Client should have received Hep A - single antigen client notified to come in for Hep A vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Her arm swelled from injection site to above elbow. Hot to touch/red/swollen. Recommended she see MD in case it was infected.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Joint range of motion decreased
Clinical narrative: Patient experienced discomfort and lower range of motion following the injection on 10-10 but states continued loss of motion over time reported 13 days post injection.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: Patient's daughter states that about 3 hours after the patient received the vaccine the patients arm was swelling and producing red welts. They called the primary physician and the office recommended BENADRYL. Symptoms resolved within 2 days no office visit required.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: 2 cm area of erythema and induration of both thighs at site of vaccine. Rx: TYLENOL 80 mg po Q6 hrs prn pain/fever.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-FEB-2015, the patient was vaccinated with an improperly store dose PNEUMOVAX 23 0.5ml, (lot #K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion was 24 hours with the lowest recorded temperature of -1 was exposed to temperature excursion once. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored VAQTA (lot # M012261 with expiration date of 01-FEB-2018; strength, dosage, frequency and route unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; strength, dosage, frequency and route unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of 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: Information has been received from a Licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M006112 with expiration date of 16-NOV-2017; strength, dosage, frequency and route unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (Lot # M000592 with expiration date of 12-Oct-2017; strength, dosage, frequency and route unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. 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 a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were unknown. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and route unknown, lot # M009764, expiration date: 23-FEB-2018). The vaccines were stored at 28 Fahrenheit degree for 18 hours. There was no previous temperature excursion. The call was not due to a "data logger". No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. 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 physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 520 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. 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 physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 632 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. 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 physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. 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 physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-JAN-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 344 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of 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 refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses (incorrect product storage) of ROTATEQ (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. 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 physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HIBV, HPV9, MMR, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age. On an unknown date, the patient was vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # L040961, 19-OCT-2017. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB, M010440, 09-DEC-2018. On an unknown date, the patient was vaccinated with improperly stored oral ROTATEQ, M019708, 25-OCT-2017, L039141 16-AUG-2017, M002252 28-FEB-2017, M006112 16-NOV-2017. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 L043214, 30-AUG-2017. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB M010212, 21-JAN-2019. Temperature 26 Fahrenheit 5 hours, 52 F 35mins and the vaccine was administered. There was no previous excursion. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses of M-M-R II (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and route unknown, lot# M022556, expiration date: 26-MAY-2017; lot# reported as L048848, expiration date: 09-AUG-2018). No adverse effects were reported. This is one of several reports received from the same reporter. Lot number L048848 is not valid for VAQTA. 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 registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses of RECOMBIVAX HB (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 27-JUN-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K002527, expiry date: 18-FEB-2016. No adverse events were reported. No information was provided. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses of VAQTA (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of 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 an office manager refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. Reporter stated that on unknown dates, the patient may have been vaccinated with improperly stored doses of ROTATEQ (lot # L046320, expiry date: 29-SEP-2017; lot # L038536, expiry date: 19-AUG-2017. Reporter mentioned that the vaccine was exposed to 31.8 F for 62 hours. A data logger was used to record temperatures. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. Reporter stated that on unknown dates, the patients may have been vaccinated with improperly stored doses of GARDASIL 9 (lot # M003659, expiry date: 20-SEP-2017; lot # L043213, expiry date: 28-AUG-2017; lot # L043214, expiry date: 30-AUG-2017). Reporter mentioned that the vaccine was exposed to 31.8 F for 62 hours. A data logger was used to record temperatures. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL 9 injection (lot number/expiry date and dosage not reported). On an unknown date, on an unspecified time, the patient experienced an unspecified adverse reaction. No Product Quality Complaint (PQC) was involved. Action taken with GARDASIL 9 was unknown. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and GARDASIL 9. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 66 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, lot # and expiry date were not specified). The patient came the next day to the physician's office complaining of pain in her arm where the vaccine shot had been administered. The outcome of the event was unknown. The causality of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient. The patient's concurrent condition and historical condition were not reported. It was reported that the patient had no known drug reactions or allergies. On 12-SEP-2016 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unspecified) (dosing regimen and frequency unknown). Concomitant therapies included LYRICA, ARMOUR THYROID and SINGULAIR. On approximately 21-SEP-2016 (reported as approximately two weeks ago), the patient experienced bronchitis. The patient visited a physician on an unspecified date and was prescribed Prednisone (manufacturer unknown) for the event of bronchitis. It was reported that at the time of this report the patient had not started taking Prednisone (manufacturer unknown). The outcome of bronchitis is unknown. Causality assessment was not provided by the reporter. There was no Product quality issue (PQC) involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a multiple patients of unknown age. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 L043214, 30-AUG-2017. Temperature 26 Fahrenheit 5 hours, 52 F 35mins and the vaccine was administered. There was no previous excursion. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified  patient's were vaccinated with improperly stored doses (incorrect product storage) of (Oka/Merck) VARIVAX (lot, expiry date and dosage regimen was unknown for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.