chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness, Syncope, Tremor
Clinical narrative: Patient a 15 year old teenage male had just been vaccinated for the first time with the HPV Gardasil 9 Vaccine. Approximately 5 mins later, while at checkout patient started violently shaking and collapsed onto the floor at the Pediatrician's office with continued shaking and passed out briefly. Patient hit the back of his head on the floor. Patient had just been given a "clean bill of health" from his 15 year old physical.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other bacterial vaccines, subs encntr on 2017-06-16.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Vaccine expired by 3 days.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cold sweat, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Severe Headache. Severe Body Aches and Pains. Fever 101-101.5. Chills. Sweating/Clammy. Extreme Fatigue.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Severe Headache. Severe Body Aches and Pains. Fever 101-101.5. Chills. Sweating/Clammy. Extreme Fatigue.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Feeling of body temperature change, Headache, Impaired driving ability, Impaired work ability
Clinical narrative: Patient was having hot and cold flashes and pain from neck to elbow and under the arm. Said she would have gone to the ER had she been able to get out to drive. Severe headache. Patient had to leave work.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Patient was having hot and cold flashes and pain from neck to elbow and under the arm. Said she would have gone to the ER had she been able to get out to drive. Severe headache. Patient had to leave work.
Age: 43.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into clinic to have the back of the right arm above elbow assessed by a nurse. Redness and swelling noted to be the diameter of a tennis ball; warm to touch. Var vaccine given SQ in this arm on 06/21/2017. Pt educated about s/sx of var administration, instructed to apply cold compress to site,and take Tylenol or Motrin for pain. And in the event that sx do not improve or any further concerns, to follow up with physician.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram abnormal, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever with abnormal movements. Infant had flexion/stiffening of upper extremities on several occasions.
Age: 41.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Impaired work ability, Injection site pain, Pain in extremity
Clinical narrative: Pt received Hep A in right arm, Hep B in left arm. Pt experienced mild pain upon injection in right arm followed by more severe pain the next morning. Left arm pain started several days later. Pt went to ER on 5/24 and was evaluated and discharged with rx for ibuprofen and note to be off work. Pt returning to dr on 6/22 for reevaluation of continuing pain.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event noted.  Administrator error- he was not due to get an IPV yet and I administered it.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Mobility decreased, Pain
Clinical narrative: HPV Vaccine was administered at 10:41am in her left Deltoid. Immediately after receiving vaccine, the patient lifted her arm and said it was very painful. The nurse recommended warm compresses and elevation of the arm. Patient left office and called back at 11:20 with increased concern about pain and tingling in left arm that radiated to her left side and left leg. She arrived back to the clinic and was seen by the provider at 11:45. Vital signs were within normal limits and assessment was benign with the exception of her arm being red and skin mottled on her left arm and hand. She reported her skin hurt all over and she said she was unable to move her arm. She received TYLENOL and BENADRYL and within 30 minutes she was feeling much better and just had mild pain at the injection site.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Pain of skin, Paraesthesia, Skin discolouration
Clinical narrative: HPV Vaccine was administered at 10:41am in her left Deltoid. Immediately after receiving vaccine, the patient lifted her arm and said it was very painful. The nurse recommended warm compresses and elevation of the arm. Patient left office and called back at 11:20 with increased concern about pain and tingling in left arm that radiated to her left side and left leg. She arrived back to the clinic and was seen by the provider at 11:45. Vital signs were within normal limits and assessment was benign with the exception of her arm being red and skin mottled on her left arm and hand. She reported her skin hurt all over and she said she was unable to move her arm. She received TYLENOL and BENADRYL and within 30 minutes she was feeling much better and just had mild pain at the injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of VARIVAX subcutaneously, lot #: M041081, expiration date on 06-OCT-2018, lot #: M044347, expiration date on 04-NOV-2018 and lot number reported as: M044307, expiration date on 04-NOV-2018 (strength, dose number and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown. It was reported that the dose of VARIVAX M041081 was improperly stored at 14° Fahrenheit degrees for 34 minutes; the dose of VARIVAX lot number reported as: M044307 was improperly stored at 6° Fahrenheit degrees for 4 hours and 49 minutes and the dose of VARIVAX lot #M044347 was improperly stored at 6°F to 14°F (10°F-4 cycles) for 30 minutes. This excursion was detected due to a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1706USA010046.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender.  Medical history, concurrent conditions and concomitant medications were unknown by the reporter.  In approximately 2014 (reported as about three years ago), the patient received ZOSTAVAX (route and lot # not provided). The patient "recently" reported to the pharmacist that they had gotten a case of shingles "later" (date not specified). The pharmacist reported that the patient looked like they had decreased symptoms. The pharmacist attributed the event to the vaccine. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an  office manager via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that the M-M-R II was reconstituted with sterile diluent (manufacturer unknown).  No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Swelling
Clinical narrative: Redness, Swelling, and Nausea.
Age: 29.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Rash, Rash erythematous
Clinical narrative: Pt states she developed redness an induration at the site of application of VZV vaccine. She states she developed a mild fever which lasted two days. As of 6/20/ 17 she states she began to develop red, itchy rashes on her face arms, abdomen, chest and back.
Age: 29.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Pt states she developed redness an induration at the site of application of VZV vaccine. She states she developed a mild fever which lasted two days. As of 6/20/ 17 she states she began to develop red, itchy rashes on her face arms, abdomen, chest and back.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eczema
Clinical narrative: Eczema rash on his face.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Dizziness, Headache, Injection site rash, Nausea
Clinical narrative: Initially dizziness and nausea occurred and began to experience a headache, body aches, vomiting, and cough. The next morning developed rash at site of injection and low grade fever. Nausea finally resolved on 06/18/17.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Initially dizziness and nausea occurred and began to experience a headache, body aches, vomiting, and cough. The next morning developed rash at site of injection and low grade fever. Nausea finally resolved on 06/18/17.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: Wrong medication was ordered for patient. Hepatitis A was ordered instead of Hepatitis B.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, TTOX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child was given vaccines dated 6-19-2017 which are expired by three days. No adverse reactions noted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Pruritus
Clinical narrative: Patient reported back to the pharmacy on 6/22/17 around 5:45PM with a very red injection site and 2 blisters around the injection site. Patient stated she did not feel like she needed to go to the doctor, and was counseled to apply some hydrocortisone cream to help with the itching.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Crying, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Large, hot red lump at injection site, extreme change in behavior (inconsolable crying, lethargy) fever pox over entire trunk and extremities.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Pyrexia, Rash pustular
Clinical narrative: Large, hot red lump at injection site, extreme change in behavior (inconsolable crying, lethargy) fever pox over entire trunk and extremities.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye pruritus, Peripheral swelling, Pruritus
Clinical narrative: Patient presents with bilateral lower extremity redness/swelling in addition to itchy skin and eyes that began approximately an hour after she had a live zoster vaccine injection. Patient denies any associated chest pain or difficulty breathing. Denies any fevers. ER treatment included Benadryl and dexamethasone IM. Beginning 6/21 AM, take prednisone 40mg once a day for next 3 days.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Muscle rigidity, Muscle tightness
Clinical narrative: Patient got light headed, started sweating and passed out. She got rigid and body tensed up a few times and then she came to and repeated this cycle about 3 times then she didn't remember what had happened. She sat in a chair for about 25 minutes and was able to leave the immunization room on her own with guidance from her mother.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Angioedema, Pyrexia, Skin warm, Somnolence
Clinical narrative: Became Drowsy, feeling warm, fever started. Noted to have angioedema in right upper thigh.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Dizziness, Echocardiogram, Laboratory test, Oesophagogastroduodenoscopy
Clinical narrative: Dizziness, lightheaded, tachycardia, blurred vision, syncope episode.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tachycardia, Tilt table test, Vision blurred
Clinical narrative: Dizziness, lightheaded, tachycardia, blurred vision, syncope episode.
Age: 0.33
Sex: M
Vaccine: 6VAX-F
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 3 inch diameter red swollen leg and hot to the touch.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Ultrasound scan, X-ray limb
Clinical narrative: (L) arm pain and swelling general malaise.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever one day after vaccination. Skin rash 4 days after vaccination.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local Rxn to site of injection Sx onset 2 days after injection Redness and swelling.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Syncopal episode 10 minutes post vaccination (when leaving office) - writer arrived to assist pt within 1 minute post event - pt states "I don't know what happened - I just felt dizzy and must of went down". Pt oriented x 3, BP = 110/76; P = 68; R = 16. After 10 minutes, pt reports ok to leave. Denies any adverse effects. Boyfriend here and will drive pt home.
Age: 5.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Administration of incorrect vaccine, ZOSTAVAX instead of VARIVAX. No known ill effects.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Injection site indentation, Local swelling, Vaccination site atrophy
Clinical narrative: After initial vaccination had some localized redness and swelling. Six months after vaccination started noticing a indentation where the vaccine was given. She came into our office almost a year from administration with subq tissue atrophy where the vaccine was administered.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Lip swelling
Clinical narrative: Patient developed erythema, hives, and itching of the upper arms, chest and face. Slight lip swelling after administration of PPSV23. Treated with 2 doses of BENADRYL 25 mg PO, symptoms improved.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed erythema, hives, and itching of the upper arms, chest and face. Slight lip swelling after administration of PPSV23. Treated with 2 doses of BENADRYL 25 mg PO, symptoms improved.
Age: 19.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse affects noted. 19 year old patient received Adult dose of Hep B instead of the Pediatric dose. Pt. verbalized no reaction to Hep B vaccination.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration, Local reaction, Skin warm, Tenderness
Clinical narrative: Localized reaction, 3.5x2.5cm of induration, erythema - slightly warm and slightly tender.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Rash, Skin warm
Clinical narrative: Soreness, hot "feverish", achiness per pt cellulitis rash. Placed on steroid and KEFLEX.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt came back with swollen, warm, itching arm next day. Recommended pt to tk BENADRYL and ice compress. Pt stated swelling is going down.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth, Peripheral swelling
Clinical narrative: "Knot" at injection site: Left arm (upper) with redness and warmth,. Swelling is worsening to include entre arm-may have to have surgery if gets worse, per MD.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Hives (off and on). C/O hives since 15 month WCC in which she received 4th DTaP and also finished 10 day course of amoxicillin around that time. Parents have not noted any other symptoms. No recent changes in soaps, lotions, detergents, foods, etc.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction: Raised, red, hot itchy, x2 inches in diameter. Tried ice, did not help.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt has a red rash at injection site says dark red, then had a lighter ring around it that was getting larger. Estimate placing hand in "C" shape and placing on arm is how big. Pt says has pain and low grade fever. Recommended ice and TYLENOL and monitor. Redness started going down on day 3. States like bump site of angry in arm.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Head injury, Syncope, Tooth fracture
Clinical narrative: Syncope-episode after receiving GARDASIL 9 and Meningococcal vaccines. Syncope episode happened about 2-3 minutes after immunizations were given. Due to the syncope episode, patient suffered a head injury and a chipped tooth. Patient was eval by MD after incident. Patient recovered about an hour after vaccination.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm became red, hot, and swollen all the way to her elbow. Her arm is painful and she has terrible malaise.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Swelling
Clinical narrative: Redness, swelling, edema from deltoid down to elbow.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Tremor
Clinical narrative: Chills, shaking, headaches - went to hospital ER - ER MD feels unlikely vaccine reaction - was discharged same day from ER - was completely "fine" 24 h after incident.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cough, Dermatitis diaper, Diarrhoea, Rhinorrhoea
Clinical narrative: Pt. rec'd routine vaccines 06-12-17 at WCE. Diarrhea began that evening after approximately 8-10 stools (Loose)/day continued. Afebrile. Cough and green nasal drainage at OV 6-22-17. (WT 6/22). Also seen 6/16/17 for diaper rash. Supportive Tx.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Headache, Syncope
Clinical narrative: Patient was sitting in the chair where the shot was given and fainted. He fell straight to the floor hitting his head and started shaking. When he came to, he couldn't feel his arms or legs. Very confused.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Concussion, Confusional state, Dizziness, Fall, Head injury
Clinical narrative: Patient was sitting in the chair where the shot was given and fainted. He fell straight to the floor hitting his head and started shaking. When he came to, he couldn't feel his arms or legs. Very confused.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Headache, Loss of consciousness, Neurological examination abnormal, Sensory loss, Syncope
Clinical narrative: Patient was sitting in the chair where the shot was given and fainted. He fell straight to the floor hitting his head and started shaking. When he came to, he couldn't feel his arms or legs. Very confused.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Tremor
Clinical narrative: Patient was sitting in the chair where the shot was given and fainted. He fell straight to the floor hitting his head and started shaking. When he came to, he couldn't feel his arms or legs. Very confused.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 year old female patient who was allergic to sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA). Information regarding the patient's pertinent medical history and concomitant medications was not provided. On 10-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection, in the right arm, lot # M038351 with expiration date on 06-DEC-2017 (dose was not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot # M034443 with expiration date on 20-APR-2019 (dose was not reported). On 12-JUN-2017, the patient developed a red area at the injection site measuring approximately 4 inches. The patient took diphenhydramine hydrochloride (BENADRYL) and applied ice packs to the area as a treatment. The patient had not recovered from the event at the time of the report. The relatedness between the event and suspect therapies was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 year old female patient who was allergic to sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA). Information regarding the patient's pertinent medical history and concomitant medications was not provided. On 10-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection, in the right arm, lot # M038351 with expiration date on 06-DEC-2017 (dose was not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot # M034443 with expiration date on 20-APR-2019 (dose was not reported). On 12-JUN-2017, the patient developed a red area at the injection site measuring approximately 4 inches. The patient took diphenhydramine hydrochloride (BENADRYL) and applied ice packs to the area as a treatment. The patient had not recovered from the event at the time of the report. The relatedness between the event and suspect therapies was not reported. Additional information has been requested.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Patient got rotavirus vaccine 6/8/17 and developed intussusception three days later.
Sex: F
Vaccine: VARZOS
Symptoms: Granuloma annulare
Clinical narrative: This spontaneous report was received from a 63-year-old female patient, who was reporting on herself. The patient was also a nurse. Her concurrent conditions included high cholesterol. She did not have any drug reactions or allergies. No other information regarding the patient's pertinent medical history was provided. On 12-AUG-2016 (also reported as "when she was 52 years of age"), the patient was vaccinated with ZOSTAVAX injection, via subcutaneous route (dose, site of administration, lot number and expiration date were not reported) for prevention of shingles. Concomitant therapies included unspecified over-the-counter products and lisinopril (manufacturer unknown). On an unknown date, the patient developed granuloma annulare. The physician's assistant, who was the patient's primary doctor, knew of her condition. The patient was prescribed prednisolone (manufacturer unknown), a 4 mg solumed pack. There were no laboratory diagnostic studies performed and she was not given another dose of vaccine. There was no product quality complaint (PQC) involved. The outcome of granuloma annulare was not reported. The reporter considered granuloma annulare to be possibly linked to ZOSTAVAX. Additional information is not expected as no consent to contact the physician was granted.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JUL-2016, the patient was vaccinated with a dose of M-M-R II lot # L030162 (dose, route of administration, albumin status and expiry date were not reported). On 01-AUG-2016, the patient was vaccinated with a dose of VARIVAX lot # reported as L048466 (dose, route of administration and expiry date were not reported). Concomitant therapies included sterile diluent. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Extra dose administered
Clinical narrative: This spontaneous report was received a female patient of unknown age, who was reporting on herself. On an unknown date, the patient had been vaccinated with an unspecified shingles vaccine. No other information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a booster dose (also reported as "doses") of shingles vaccine ZOSTAVAX could not be ruled out) (manufacturer, route of administration, lot number and expiration date were not reported). On an unknown date the patient experienced asthma. It could not be determined if the patient had asthma prior to receiving shingles vaccine (manufacturer unknown). As treatment for asthma, the patient was taking mometasone furoate (+) formoterol fumarate (DULERA) inhalation. The outcome of asthma was not reported. The relatedness between asthma and shingles vaccine (manufacturer unknown) was not provided. Additional information is not expected as no contact details were provided.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 21-year-old male patient. No information regarding the patient's pertinent medical history and drug reactions or allergies and concomitant therapies was provided. On 19-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # M040412, expiration date: 30-JUN-2019; exact dose and route of administration were not reported). On 26-MAY-2017, the patient was inadvertently vaccinated with another dose of GARDASIL 9 injection (lot # M040412, expiration date: 30-JUN-2019; exact dose and route of administration were not reported). The pharmacist was not aware about the fact that the patient had already received the first dose. No adverse effects were reported. No product quality complaint 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 nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. Beginning on 23-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M048203, expiration date 07-DEC-2018 and lot # M047662, expiration date 02-DEC-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). There was no symptoms reported. Administered doses of vaccines experienced the temperature excursion of -10 degrees Celsius for 2 hours and 50 minutes. Digital data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA010478:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on 05-JUN-2017, the patient was vaccinated with an expired dose of VARIVAX with lot number L019130 and expiration date on 27-MAY-2017, administered for prophylaxis (dose, dose number, route of administration and anatomical location were not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a currently 20-year-old female patient. The patient's sibling: twin sister. The patient's other concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient received the third dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for prevention of human papillomavirus. On the same day, the patient also received a shot of TRUMENBA (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient fainted. The patient sought medical attention by seeing the physician. The product quality complaint was not involved. At the time of the report, the outcome of the event was recovered. The causal relationship between the event and GARDASIL 9 was not reported. The patient's twin sister who also fainted after GARDASIL 9 administration (captured in MARRS# 1706USA002769). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA002769.
Sex: F
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a registered nurse who was referring to a female patient of unknown age. The patient's medical history included debridement, laser therapy and scraping methods for treatment of plantar warts (all unsuccessful). There was no information regarding the patient's concomitant medication, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection, as a treatment for plantar warts (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the GARDASIL 9 cured the patient's plantar warts and it was reported that the treatment was successful. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9 lot # M036059 with an expiration date of 03-JUN-2019, or N002720 with an expiration date of 12-MAY-2019 (single dose, route of administration and anatomical location were not reported) were inadvertently administered to the unspecified number of patients. No adverse effects were reported. The vaccines were exposed to temperature of 47 degrees Fahrenheit for 30 minutes before administration to the patients. There was a previous temperature excursion reported, with a temperature of 56 degrees Fahrenheit for 5 hours. The digital data logger was involved. The product quality complaint was not involved. This is one of several reports received from the same reporter. Is not expected, as there was no consent for further contact. Sender's Comments: US-009507513-1706USA009733: US-009507513-1706USA009734.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients were administered doses of improperly stored ROTATEQ, orally, lot# L046318 with expiration date on 28-SEP-2017 and lot# M007124 with expiration date on 05-OCT-2017 (doses were not reported). No adverse effects were reported. Administered doses of vaccines experienced a temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit, which lasted for 4 full days. No previous temperature excursion was reported. A digital data logger was not involved in recording the excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004376: US-009507513-1706USA004377: US-009507513-1706USA004378: US-009507513-1706USA002585:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 08-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL 9 injection (lot # L048237, expiry date 08-MAY-2017, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients were administered improperly stored doses of GARDASIL 9 (dose, route of administration and anatomical location were not reported) as prophylaxis on the following dates: with lot# L024993 and expiration date of 17-OCT-2017 on 14-JUL-2016 as well as in the period from 18-JUL-2016 to 22-JUL-2016 and with lot# L036301 and expiration date of 20-DEC-2017 on 16-SEP-2016. The doses of vaccine with lot# L024993 and expiration date of 17-OCT-2017 were stored at the following temperatures: on 14-JUL-2016 at 9.1 degrees Celsius (C) for 8 hours, on 18-JUL-2016 at 15C for 8 hours, on 19-JUL-2016 at 10C for 8 hours, on 20-JUL-2016 at 34.9 degrees Fahrenheit (F) for 8 hours, on 21-JUL-2016 at 34.5F for 8 hours and on 22-JUL-2016 at 34.5F for 8 hours; with lot# L036301 and expiration date of 20-DEC-2017 on 16-SEP-2016 at 47.7F for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. It was also reported that several doses of the improperly stored GARDASIL 9 with the above mentioned lot numbers and expiration dates, which underwent temperature excursions on the same dates, were not administered to the patients. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006146: US-009507513-1706USA006147: US-009507513-1706USA006149: US-009507513-1706USA006151: US-009507513-1706USA004143: US-009507513-1706USA006150.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a physician concerning an unspecified patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis, reconstituted with 0.4 % saline solution (manufacturer unknown), instead of the sterile diluent (MRK). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Vaccination failure, Varicella post vaccine
Clinical narrative: Information has been received from GSK with assigned other company number(MFC# US2017GSK086689) on 16-JUN-2017. This spontaneous report as received from a physician via company representative refers to an adolescent female patient of unknown age. On an unknown date the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot#, dose and route were not reported) for prophylaxis. Other suspect therapies included mepolizumab(NUCALA)(indication, dose, route and frequency were not reported). The physician mentioned that the patient that after approximately her 3rd dose of mepolizumab(NUCALA) had an exposure to someone with chickenpox and got sick of chickenpox. Her other schoolmates did not get infected. She had a complete history of chickenpox vaccination (vaccination failure). Mepolizumab(NUCALA) was interrupted. The outcome of chickenpox and vaccination failure was unknown. It was unknown if the reporter considered chickenpox and vaccination failure to be related to varicella virus vaccine live (Oka/Merck)( manufacturer unknown) and mepolizumab(NUCALA). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On 19-JUN-2017, the patient was inadvertently vaccinated with a dose of VARIVAX (for prophylaxis, lot # M043582, expiration date 28-OCT-2018; dose and route of administration were not reported) instead of ZOSTAVAX. The dose of VARIVAX was reconstituted with sterile diluent. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. In June 2017, the patient was vaccinated with the improperly stored (in 7.2 degrees Fahrenheit for 30 minutes) dose of PROQUAD (for prophylaxis, lot # M014301, albumin status rHA, expiration date 22-SEP-2017; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. Data logger was involved. No previous temperature excursion and no adverse event (reported as no symptoms) were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010443.
Sex: U
Vaccine: VARCEL
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. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On 12-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot #N000683, expiry date: 06-JAN-2019 (dosing details not reported) which was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints This is one of several reports received from the same reporter.  Additional information has been requested; Sender's Comments:  US-009507513-1706USA007776:
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65 year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. It was reported that, on 19-MAY-2017, an unspecified number of doses of ZOSTAVAX (lot # M035695, expiration date 07-NOV-2017), were incorrectly stored at a temperature between 6°F and 14°F, during 1 hour and 15 minutes; and later, on 10-JUN-2017, a dose of the improperly stored ZOSTAVAX was administered to the patient (dose, route and anatomical site of injection were not reported), for prophylaxis. The vaccine was administered along with a sterile diluent, with lot # M024782 and expiration date 23-FEB-2019. The report was because of a data logger and there were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of PROQUAD lot #: M044020, expiration date on 01-MAY-2018 (strength, dose number and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown. It was reported that the dose of PROQUAD was improperly stored at 6 °F to 14 °F (10 °F- 4 cycles) for 4 hours 49 minutes. This excursion was detected due to a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1706USA006813.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. In June 2017, the patient was vaccinated with the improperly stored (in 7.2 degrees Fahrenheit for 30 minutes) dose of PROQUAD (for prophylaxis, lot # M014301, albumin status rHA, expiration date 22-SEP-2017; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. Data logger was involved. No previous temperature excursion and no adverse event (reported as no symptoms) were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008497.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. Beginning on 23-MAY-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 Plaque-Forming Units (PFU) lot # M037654, expiration date 29-NOV-2017 and lot # M035149, expiration date 31-OCT-2017 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). There was no symptoms reported. Administered doses of vaccines experienced the temperature excursion of -10 degrees Celsius for 2 hours and 50 minutes. Digital data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA015528:
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypotonia, Pallor
Clinical narrative: Limited information. Child was taken to the ED where he was admitted for observation. Child had an episode of pallor and being limp during the evening/night which prompted the parent to take the child to the ED as a precaution. The ED reported the admit to the provider in our office this AM and stated the child had been stable since arriving at the facility.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, improperly stored doses of VARIVAX lot # M041513 with expiration date 11-OCT-2018, lot # M047660 with expiration date 02-DEC-2018 and lot # M040139 with expiration date 29-SEP-2018 (dose, route of administration and anatomical location were not reported) were administered to the patients. No adverse effects were reported. It was reported that the vaccines were exposed to temperature between 6 and 14 degrees Fahrenheit for 174 hours. No previous temperature excursion was reported. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-0009507513-1706USA004366: US-0009507513-1706USA010087:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous was received from a 60-year-old female company representative, referring to herself. The patient had no medical history, concomitant medications nor concurrent conditions. On 18-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not reported). On 20-MAY-2017, the patient experienced injection site reaction, which was swollen, red, itchy, painful and was about 5-7 cm in diameter. On the same day, the patient also noticed "something that looked like shingles" on the inside portion of her lip, extending to the outer portion of her lip and being red and painful. Moreover, there was a bubble on the inside of her lip which was filled with liquid. The patient did not seek for any medical attention, but stated that she would if the symptoms got worse. No treatment was given for the events at the time of the report.  The patient recovered fully from the injection site reaction on approximately 27-MAY-2017 (reported as "in about a week"). The patient did not recover from "something that looked like shingles" on the patient's lip and the "bubble filled with liquid" at the reporting time (reported as the symptoms on her lip were not getting any better, nor any worse at the time of the report). The relatedness between the events and the suspect therapy was not reported. Additional information is not expected as there was no consent for further contact.