chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, Tenderness, Swelling all around left bicep on inside of arm.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort
Clinical narrative: Patient has been having above the chest tightness. finds it hard to explain but onset night of flu shot couple hours after. She feels it is worse when she bends over to pick something up.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Periorbital cellulitis, Periorbital oedema, Swelling face
Clinical narrative: Facial swelling on 10/14/17. She took BENADRYL and swelling resolved. On 10/23/17, she was placed on Observation Unit with periorbital edema and redness. She was diagnosed with periorbital cellulitis. She was treated with steroids, Clindamycin and PEPCID.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: Redness/rash around injection site, itching around injection site, headache, and potential low grade fever.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Ear pain
Clinical narrative: Patient reports dizziness and ear pain. After receiving the second dose of FLUZONE HD (first dose 9/25/17) at approximately 9:30 AM on 11/3/17 patient reports to have experienced dizziness starting later that night. Did not hear back from the patient or caregiver until the morning of Monday 11/6/17 and asked if the pneumonia vaccination can cause dizziness. This is the moment the Pharmacist realized that a second FLUZONE HD was administered to the patient. Recognizing Pharmacist immediately let the patient know what had occurred and called the patient's primary care physician to let them know what had occurred. Dr. prescribed the patient Meclizine 25 mg tab four times a day to treat the symptoms of dizziness.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 18-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 platelet forming units (PFU), lot # N016090 with expiration date on 23-AUG-2017 via intramuscular route. The dose of the vaccine was reconstituted with sterile diluent (MERCK), lot # N013282 with expiration date on 23-AUG-2019 (dose was not reported). The reporter also stated that both ZOSTAVAX and sterile diluent (MERCK) were properly stored. No adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a registered pharmacist via a publicist representative, referring to an unknown number of patients of unspecified age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (strength, dose, route, anatomical location, lot number and expiration date were not provided), for immunization. It was reported that on unknown dates, the patients developed redness from the shoulder to the arm after the vaccinations with PNEUMOVAX 23, which usually resolved within 2-3 days. The pharmacist stated that he was seeing that the erythema occurred more frequently. The current status of any of the affected patients with erythema was unknown. The causal relationship between the event and the PNEUMOVAX 23 was not reported.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Neuritis
Clinical narrative: Neuritis.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Injection site movement impairment, Injection site pain, Screaming, Weight bearing difficulty
Clinical narrative: Started screaming and wouldn't bear weight on leg screams when you touch her leg and won't move it.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: X-ray normal
Clinical narrative: Started screaming and wouldn't bear weight on leg screams when you touch her leg and won't move it.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fluid retention, Joint swelling, Peripheral swelling
Clinical narrative: About 6 hours after vaccine patient had swelling/retaining water hands/ankles. Patient took LASIX and swelling was gone Wednesday morning.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Patient received shot on 11/7/17. Patient presented to pharmacy on 11/9 claiming cellulitis in arm with an antibiotic for KEFLEX.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, C-reactive protein normal, Fatigue, Full blood count normal, Metabolic function test normal
Clinical narrative: Pt called on 9/14/17 w/ complaining of weakness and fatigue as well as nausea and generalized myalgias was seen in Urgent Care on 9/18/17 with continued c/o's and again on 9/27/17 with off and on sx's slowly resolving.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Red blood cell sedimentation rate increased
Clinical narrative: Pt called on 9/14/17 w/ complaining of weakness and fatigue as well as nausea and generalized myalgias was seen in Urgent Care on 9/18/17 with continued c/o's and again on 9/27/17 with off and on sx's slowly resolving.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Amblyopia, Strabismus
Clinical narrative: Development of strabismus and amblyopia.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Malaise, Peripheral swelling
Clinical narrative: Swollen arm, patient not feeling well.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient called the following day (more than 24 hours). She said that the night of the vaccine (11/7/17) she experienced redness, swelling, heat and soreness around the injection site and traveled to above the elbow, as well as dripping down the throat and coughing. She took Ibuprofen 11/7/17. She called and spoke to the pharmacist 11/8/17, 5:40 pm, to report the reaction. The dripping down the throat and coughing had cleared, but she still had the reaction on her arm and was feeling nauseated. This is when she remembered her allergy to mammalian meat and disclosed it, along with that she ate ground beef for dinner. The patient read her VIS and thought she was just having a typical reaction, but wanted to check. She was instructed to take ZYRTEC or BENADRYL (she had BENADRYL at home) and to apply a cool compress. Also, if her reaction got worse she was instructed to go to the ER. She did state that she had an EPIPEN at home if she needed it. A follow up call was initiated at 9:15 am, 11/9/17, however a message had to be left.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Upper-airway cough syndrome
Clinical narrative: The patient called the following day (more than 24 hours). She said that the night of the vaccine (11/7/17) she experienced redness, swelling, heat and soreness around the injection site and traveled to above the elbow, as well as dripping down the throat and coughing. She took Ibuprofen 11/7/17. She called and spoke to the pharmacist 11/8/17, 5:40 pm, to report the reaction. The dripping down the throat and coughing had cleared, but she still had the reaction on her arm and was feeling nauseated. This is when she remembered her allergy to mammalian meat and disclosed it, along with that she ate ground beef for dinner. The patient read her VIS and thought she was just having a typical reaction, but wanted to check. She was instructed to take ZYRTEC or BENADRYL (she had BENADRYL at home) and to apply a cool compress. Also, if her reaction got worse she was instructed to go to the ER. She did state that she had an EPIPEN at home if she needed it. A follow up call was initiated at 9:15 am, 11/9/17, however a message had to be left.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis treated with cephalexin.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, red area about 1inch diameter. Zyrtec tables. Resolved in 2-3 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Malaise, Nausea, Rash
Clinical narrative: Headache, nausea, weakness, shakiness from about 4-5 days after immunization. Immunization date is estimated, as vaccination was administered at primary care office "about a month ago." Malaise persists and nausea is improved but persists. Since flu vaccination pt had 3 visits with different providers at primary care. Pt was told the rash was "not hives." Rash persists & she will go to dermatology today. Upon my request that practice submit a VAERS report, I learned there is no documentation of any adverse events, rash began before the vaccine was administered and other symptoms are not documented.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Headache, nausea, weakness, shakiness from about 4-5 days after immunization. Immunization date is estimated, as vaccination was administered at primary care office "about a month ago." Malaise persists and nausea is improved but persists. Since flu vaccination pt had 3 visits with different providers at primary care. Pt was told the rash was "not hives." Rash persists & she will go to dermatology today. Upon my request that practice submit a VAERS report, I learned there is no documentation of any adverse events, rash began before the vaccine was administered and other symptoms are not documented.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm reported by patient to be swollen twice normal size and warm/painful.
Age: 3.0
Sex: M
Vaccine: FLU4, MMR, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On day after receiving above, child developed diffuse swelling, erythema, warmth, and itchy over anterolateral rt thigh, nontender. No fever. No other problems. (Family leaving for 2 month visit on 11-10-17).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Mobility decreased, Myalgia, Pain, Skin warm
Clinical narrative: Extreme soreness, warmth, no redness, patient had to call in for work shift the next day. Still now have severe muscle soreness, difficulty lifting, muscle aches, trouble moving arm. Pain and soreness somewhat alleviated with naproxen twice daily.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Headache, Syncope
Clinical narrative: Child left exam room went to check out and fainted. Brought back to exam room, laid down on exam table, given H2O and TYLENOL. She said her head hurt. Dr. checked her over and said ok to go home. Mom called back 2 hours later with symptoms of a possible head injury. CT scan ordered 11/6/2017 and results came back negative. Dr. called mom and gave results of scan.
Age: 25.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Fall, Hyperhidrosis, Hypoacusis, Hypotension, Loss of consciousness
Clinical narrative: Patient has high blood pressure and anxiety about shots. He received 2 shots. After the shots, he walked to his cart and fell/passed out. He was moaning on the ground. He said he couldn't see or hear when he was put in a chair and was very pale/sweating. His BP was low when taken. He was given a Coke and peanut butter crackers to eat. After he sat for awhile, he felt better after drinking the Coke and eating the crackers. He left the store with the person he came with on his own.
Age: 25.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Moaning, Pallor, Visual impairment
Clinical narrative: Patient has high blood pressure and anxiety about shots. He received 2 shots. After the shots, he walked to his cart and fell/passed out. He was moaning on the ground. He said he couldn't see or hear when he was put in a chair and was very pale/sweating. His BP was low when taken. He was given a Coke and peanut butter crackers to eat. After he sat for awhile, he felt better after drinking the Coke and eating the crackers. He left the store with the person he came with on his own.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Injection site began getting red and hot per mom in the evening of 11-07-17. Child was brought to our office on 11-08-17 at 09:40 AM and was found to have a bright red area, that was hot to the touch measuring 10cm X 5cm. There was also a knot at the injection site that was 3cm X 3.5 cm. Child was given Cefdinir 250 mg/ 5ml with the directions to take 6 ml BID X 10 days. Also was told to take 7.5 ml of BENADRYL Q 6 hours. Child was rechecked on 11-09-17 11:20 AM and still had basically the same measurement of redness but it was only pink and the heat was totally gone. The knot had shrunk to approximately the size of a "pea".
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram head normal, Dyskinesia, Electroencephalogram normal, Full blood count normal, Gaze palsy
Clinical narrative: 11/03/2017 tonic straightening of both lower extremities, failure to respond to stimulation and left upward gaze.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Influenza virus test negative, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Respiratory syncytial virus test negative, Scan with contrast normal
Clinical narrative: 11/03/2017 tonic straightening of both lower extremities, failure to respond to stimulation and left upward gaze.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: 11/03/2017 tonic straightening of both lower extremities, failure to respond to stimulation and left upward gaze.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT ARM IS RED AND SWOLLEN FROM INJECTION.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever/chills, muscle pain, headache, tiredness. 2 days until nearly normal.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Body temperature increased, Dyspnoea, Hyperhidrosis, Laboratory test
Clinical narrative: 11/05/2017: 1:00 AM, Awaken in a complete body sweat, temp of 102, unable to breathe (panting), 3 large multicolored patches on right arm, abdominal pain. 11/05/2017: 1:30 AM, Transported to Emergency Room, via ambulance, temp 101 - 102. Treated at emergency room, temp 99.4. Released 11/05/17 at 9:30 AM.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: 11/05/2017: 1:00 AM, Awaken in a complete body sweat, temp of 102, unable to breathe (panting), 3 large multicolored patches on right arm, abdominal pain. 11/05/2017: 1:30 AM, Transported to Emergency Room, via ambulance, temp 101 - 102. Treated at emergency room, temp 99.4. Released 11/05/17 at 9:30 AM.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Skin erosion
Clinical narrative: Information has been received from a pharmacist via a company representative, referring to a elderly female patient "in her 60's". The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in May 2017 (reported as "about 5 months ago"), the patient developed an injection site reaction after receiving ZOSTAVAX. It was reported that the patient's injection site "swollen 4 inches around and the area was very raw". The reporting pharmacist stated that the patient did not seek medical attention. The outcome of all the events was reported as recovered and the causality between the vaccination with ZOSTAVAX KEYTRUDA and the events was not reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA003882: US-009507513-1711USA003883.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information was received from the physician on 16-OCT-2017. The patient was aged 18 months. On 09-MAY-2017, the patient received the improperly stored dose of PEDVAXHIB (lot # M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow up information was received from the physician on 16-OCT-2017. The patient was aged 12 weeks. On 12-MAY-2017, the patient was vaccinated with PEDVAXHIB (lot# M046140). The patient's identifiers and the patient's guardian's identifiers were provided. Sender's Comments: US-009507513-1709USA007325.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 19-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 18-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 0.83
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 10 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 19-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Full blood count normal, Shift to the right, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old female patient. The patient had no pertinent medical history and drug reactions or allergies. Concomitant therapies included amoxicillin for ear infection, ordered on 26-OCT-2017. On 26-OCT-2017, the patient was vaccinated with M-M-R II lot # M042846, expiration date 21-OCT-2018. Other suspect therapies included administered on the same day VARIVAX lot# N012486, expiration date 24-APR-2019 (reported as 20-APR-2019), PREVNAR 13 lot # R37130, expiration date 30-MAR-2018 and FLULAVAL lot # ZJ5XA, expiration date 31-MAY-2018. Dose and route of administration was not provided for any of the vaccines. On 02-NOV-2017, the patient experienced erythema multiforme and hives. Unspecified treatment was given for the events. The patient was seen in physician's office. On 03-NOV-2017, complete blood count was normal and showed right shift which might indicate an early viral illness. The outcome of erythema multiforme and urticaria was reported as recovering. The causality assessment was not provided. Upon internal review, the event of erythema multiforme was considered to be medically significant.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 29-JUL-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 07-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 07-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 07-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 05-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 08-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 11-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 11-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 14-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 15-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 01-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 04-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1709USA012770 US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 04-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 07-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown) on or about 07-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-NOV-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 15-DEC-2014, the patient sought subsequent treatment for ongoing and worsening symptoms of shingles outbreak. On or about 09-MAR-2015, the patient was treated by a physician for unresolved and worsening painful symptoms of shingles, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. The patient was prescribed acyclovir, tramadol and hydrocodone for management of her continued and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown) on or about 01-MAR-2007, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUN-2011, the patient was treated by a dermatologist for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # US-009507513-1710USA009210 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # US-009507513-1710USA009210 is being deleted from our files and the case is consolidated into case # 1711USA003871 with the correct Aware Date 18-SEP-2017.; Sender's Comments: US-009507513-1708USA011654.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Skin erosion
Clinical narrative: Information has been received from a pharmacist via a company representative, referring to a elderly female patient "in her 60's". The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in May 2017 (reported as "about 5 months ago"), the patient developed an injection site reaction after receiving ZOSTAVAX. It was reported that the patient's injection site "was swollen and also very raw". The reporting pharmacist stated that the patient went to the doctor, but the doctor did not give her anything in terms of treatment. The outcome of all the events was reported as recovered and the causality between the vaccination with ZOSTAVAX KEYTRUDA and the events was not reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA010523: US-009507513-1711USA003883.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009211 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009211 is being deleted from our files and the case is consolidated into case # 1711USA003911 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 16 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009212 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009212 is being deleted from our files and the case is consolidated into case # 1711USA003916 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.