chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Electromyogram abnormal, Electrophoresis protein normal, Hyperaesthesia, Immune system disorder, Immunology test
Clinical narrative: A plethora of irritating symptoms: Aching feet, hands, toes, fingers; muscle aches and soreness in various areas, not necessarily all at the same time; stiff and painful right middle finger when waking  in AM, which is painful to straighten out; burning sensations in various areas, again not necessarily all at the same time; skin sensitive, as when putting on pants; fasciculations in various areas, especially left hand where thumb and index finger meet; tingling sensations in arms and legs; transitory sensations of weakness in legs and arms, like when an arm or leg partially "falls asleep" or as if pressure is being applied to a "soft spot" in the armpit.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Immunology test normal, Laboratory test normal, Liver function test normal, Muscle contractions involuntary, Muscular weakness
Clinical narrative: A plethora of irritating symptoms: Aching feet, hands, toes, fingers; muscle aches and soreness in various areas, not necessarily all at the same time; stiff and painful right middle finger when waking  in AM, which is painful to straighten out; burning sensations in various areas, again not necessarily all at the same time; skin sensitive, as when putting on pants; fasciculations in various areas, especially left hand where thumb and index finger meet; tingling sensations in arms and legs; transitory sensations of weakness in legs and arms, like when an arm or leg partially "falls asleep" or as if pressure is being applied to a "soft spot" in the armpit.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Myalgia, Myositis, Nerve conduction studies abnormal, Neuropathy peripheral
Clinical narrative: A plethora of irritating symptoms: Aching feet, hands, toes, fingers; muscle aches and soreness in various areas, not necessarily all at the same time; stiff and painful right middle finger when waking  in AM, which is painful to straighten out; burning sensations in various areas, again not necessarily all at the same time; skin sensitive, as when putting on pants; fasciculations in various areas, especially left hand where thumb and index finger meet; tingling sensations in arms and legs; transitory sensations of weakness in legs and arms, like when an arm or leg partially "falls asleep" or as if pressure is being applied to a "soft spot" in the armpit.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Paraesthesia, Protein total normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: A plethora of irritating symptoms: Aching feet, hands, toes, fingers; muscle aches and soreness in various areas, not necessarily all at the same time; stiff and painful right middle finger when waking  in AM, which is painful to straighten out; burning sensations in various areas, again not necessarily all at the same time; skin sensitive, as when putting on pants; fasciculations in various areas, especially left hand where thumb and index finger meet; tingling sensations in arms and legs; transitory sensations of weakness in legs and arms, like when an arm or leg partially "falls asleep" or as if pressure is being applied to a "soft spot" in the armpit.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Itchiness, redness and swelling along length of arm with pain.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: LARGE RASH/REDNESS ON ARM, HOT, SWOLLEN, AND PAINFUL.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Patient reported shingles shortly after receiving the first series of the SHINGRIX vaccine. Patient received VALTREX from our pharmacy on 5/18. Patient reported lesions and pain lasting multiple weeks.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Eye disorder, Malaise, Pain
Clinical narrative: Patient had her second Hep B vaccine on February 13, 2017. Sometime after the vaccine, patient, told medical supervisor she didn't feel well. Patient consistently told medical staff for about a month to follow that she was having issues that she felt were related to the vaccine. Patient set an appointment with an opthalmologist for the following months of pain and illness due to almost going blind.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient came in complaining of severe pain at the injection site, very warm to touch, and patient states that the vaccine may have been administered too high above the recommended site. She states that she works for a physician office and has some clinical knowledge. She was prescribed AUGMENTIN for her possible infection.
Age: 21.0
Sex: F
Vaccine: HEP, MENB, TDAP, VARCEL
Symptoms: Fatigue, Pain, Swelling face
Clinical narrative: Client reported on 7/23/18 the following adverse reaction: She became tired and achy on Friday 7/13/18 at about 6PM. She woke up Sunday, 7/15/18 at 8:00 AM with (L) sided facial swelling and also some swelling of the right side. She has a picture of this on her cell phone. She denies numbness tingling of tongue or throat swelling. Her mom called a friend who is a nurse practitioner. The nurse practitioner prescribed prednisone on Sunday morning and they picked it up at noon. The client states it took 3-4 days for the facial swelling to go away. The achiness and the fatigue was gone by Sunday morning on 7/15/18. The client feels she is fully recovered now. The VAERS report was filled out on 8/10/18. 8/10/18 Client came in and filled out the VAERS and also a copy given to the client. 8/14/18 VAERS report faxed to the CDC.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever, weakness, loss of appetite, fatigue - 4 days duration.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose, Cold sweat, Dizziness, Headache, Photophobia
Clinical narrative: 0940-pt received two shots and walked out of office w/no symptoms. 1130-RN spoke w/mother and patient. Patient feeling dizzy, photophobic, clammy, headache and vomited. Discussed w/MD and advised to eat and drink, and come back to clinic to be checked out immediately. Chart notes that patient went to ED.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pregnancy test, Urine analysis, Vomiting
Clinical narrative: 0940-pt received two shots and walked out of office w/no symptoms. 1130-RN spoke w/mother and patient. Patient feeling dizzy, photophobic, clammy, headache and vomited. Discussed w/MD and advised to eat and drink, and come back to clinic to be checked out immediately. Chart notes that patient went to ED.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: 2 hours after immunizations - pt. developed hives - urticaria.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Throat irritation
Clinical narrative: Patient complains of dizziness and warmth feeling to throat. Medicated with BENADRYL per MD. Observed patient for approximately 40-45 min. Patient states no dizziness-no warmth feeling to throat. Patient states she feels fine. No swelling of throat, tongue or lips.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Ear pruritus, Ear swelling, Erythema, Injection site bruising, Pruritus
Clinical narrative: Patient presented with red patches on her forehead neck and chin that were itchy and swollen. Her earlobes were also itchy and swollen 3 days after she received the vaccine. She also had a large area of dark bruising on her arm where the vaccine was administered.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient presented with red patches on her forehead neck and chin that were itchy and swollen. Her earlobes were also itchy and swollen 3 days after she received the vaccine. She also had a large area of dark bruising on her arm where the vaccine was administered.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pt. went in for routine MRI and was told she had swollen lymph nodes on left armpit - (when questioned about vaccine use) - she got a SHINGRIX shot Dr. said it was probably due to vaccine because SHINGRIX causes swollen lymph nodes.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Nuclear magnetic resonance imaging abnormal, Vaccination complication
Clinical narrative: Pt. went in for routine MRI and was told she had swollen lymph nodes on left armpit - (when questioned about vaccine use) - she got a SHINGRIX shot Dr. said it was probably due to vaccine because SHINGRIX causes swollen lymph nodes.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injection site rash in a 63-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. Co-suspect products included PNEUMOVAX 23 (batch number N030847, expiry date 9th June 2019) for prophylaxis. On 30th July 2018, the patient received SHINGRIX (intramuscular) .5 ml and PNEUMOVAX 23 (intramuscular) .5 ml. On 1st August 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash and injection site warmth. On 2nd August 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were recovering/resolving and the outcome of the injection site warmth was unknown. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with SHINGRIX and PNEUMOVAX 23 on the same day, in the same arm (left deltoid). The patient experienced a red oval rash of about 4 to 5 inches long at the injection site extending into the humerus. Three days after the vaccination, the patient experienced injection site redness. The patient consulted her doctor who said that, the adverse events were expected and did not order any treatment. On Saturday, a day before reporting, when the patient had come to the pharmacy, the area was still pinkish and warm to touch but the patient indicated it had improved. The pharmacy did not know the identification of the patient's doctor.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injection site rash in a 63-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. Co-suspect products included PNEUMOVAX 23 (batch number N030847, expiry date 9th June 2019) for prophylaxis. On 30th July 2018, the patient received SHINGRIX (intramuscular) .5 ml and PNEUMOVAX 23 (intramuscular) .5 ml. On 1st August 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash and injection site warmth. On 2nd August 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were recovering/resolving and the outcome of the injection site warmth was unknown. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with SHINGRIX and PNEUMOVAX 23 on the same day, in the same arm (left deltoid). The patient experienced a red oval rash of about 4 to 5 inches long at the injection site extending into the humerus. Three days after the vaccination, the patient experienced injection site redness. The patient consulted her doctor who said that, the adverse events were expected and did not order any treatment. On Saturday, a day before reporting, when the patient had come to the pharmacy, the area was still pinkish and warm to touch but the patient indicated it had improved. The pharmacy did not know the identification of the patient's doctor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Dyspnoea, Eye swelling, Full blood count, White blood cell count increased
Clinical narrative: Patient experienced periorbital swelling and respiratory difficulty (difficulty with inspiration). He had some facial redness. All symptoms within 15 minutes of the 2 vaccinations. He received Epinephrine IM and Benadryl as treatment. About 5 hours after treatment, swelling and respiratory difficulties had completely resolved and did not return.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Eye swelling
Clinical narrative: Patient experienced periorbital swelling and respiratory difficulty (difficulty with inspiration). He had some facial redness. All symptoms within 15 minutes of the 2 vaccinations. He received Epinephrine IM and Benadryl as treatment. About 5 hours after treatment, swelling and respiratory difficulties had completely resolved and did not return.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: This spontaneous report was received from a consumer who was referring to her 14-year-old, non-pregnant female daughter. The patient had no pertinent medical history and no drug reactions or allergies. Concomitant medications included escitalopram. On 11-JUL-2018, the patient was vaccinated with the first 0.5 ml dose of GARDASIL 9 intramuscularly (site of administration, lot# and expiration date were not reported) for prevention of HPV. On the same day, while in a doctor's office, the patient passed out and had a short seizure. No treatment was given for the events. The patient did not seek medical attention. No lab diagnostic tests were performed. The outcome of the events was reported as recovered on an unspecified date in 2018. The relatedness between the events and vaccination with GARDASIL 9 was not reported. Upon internal review, the event of seizure was determined to be medically significant.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Ear pruritus, Eye pain, Eye pruritus, Eye swelling
Clinical narrative: Contracted shingles on face/eye. Symptoms one day after vaccine. Went to urgent care after it was clear that symptoms were not usual allergies. Shingles diagnosed at urgent care and confirmed the following day by eye doctor.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Multiple allergies, Ophthalmic herpes zoster, Rash
Clinical narrative: Contracted shingles on face/eye. Symptoms one day after vaccine. Went to urgent care after it was clear that symptoms were not usual allergies. Shingles diagnosed at urgent care and confirmed the following day by eye doctor.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Contracted shingles on face/eye. Symptoms one day after vaccine. Went to urgent care after it was clear that symptoms were not usual allergies. Shingles diagnosed at urgent care and confirmed the following day by eye doctor.
Age: 72.0
Sex: M
Vaccine: VARZOS, YF
Symptoms: Gingival discomfort, Herpes zoster
Clinical narrative: Patient presented with signs of irritation, redness, minor blister like formation inside the left side of the oral cavity. Signs were found during a visit to the dentist office. Signs/irritation was resolved few days later.
Age: 72.0
Sex: M
Vaccine: VARZOS, YF
Symptoms: Oral mucosal blistering, Oral mucosal erythema, Stomatitis
Clinical narrative: Patient presented with signs of irritation, redness, minor blister like formation inside the left side of the oral cavity. Signs were found during a visit to the dentist office. Signs/irritation was resolved few days later.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: The patient called the pharmacy today to report a red spot that appeared around her injection site from PREVNAR (PCV13) which was administered on 08/06/2018 at this pharmacy. She stated the redness appeared yesterday or today (08/13 or 08/14/2018) and just started get slightly tender and itchy. She stated the red-colored area was about the size of the nickle. She later came into the pharmacy to show me, which showed clear redness in almost a perfect circle (above the size of a nickle o r quarter) around her injection site. Also, her entire deltoid area surrounding the round circle of her left arm seemed a little swollen and pinkish compared to her other arm. Her arm was also warmer to touch than her other arm. She reiterated that she had just noticed the red spot yesterday while showing after she had done some mild physical activity (gardening and lawn work). She said she had called her doctor, who had instructed her to consult with the pharmacy for guidance. I told her that she should monitor her symptoms closely and any worsening (ie, systemic effects such as hives, fatigue, nausea, chills, sudden drop in blood pressure, or swelling of her airway/difficulty breathing, fever, etc.) should be immediately brought to the attention of a physician. In the meanwhile, I recommended BENADRYL (DIPHENHYDRAMINE) to help reduce any allergic reaction and itching. I also recommended taking NSAIDs such as IBUPROFEN to help reduce inflammation/pain + TYLENOL (ACETAMINOPHEN) + COLD COMPRESS (ice on/off 10 minutes cycles). I urged her to seek immediate medicalattention if such symptoms occurred and not hesitate to go to the hospital emergency department. I also recommended she take BENADRYL + ingest PLENTY OF WATER to maintain blood vessel volume in the case of anaphylactic reaction. Patient understood recommendations and was thankful for taking the time to assess her situation.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported redness, itching and swelling at the injection site that was occurring a few days after vaccination.
Sex: M
Vaccine: MMR, MMRV
Symptoms: Computerised tomogram thorax abnormal, Condition aggravated, Dyspnoea exertional, FEV1/FVC ratio, Laryngeal operation
Clinical narrative: This literature market report has been received from authors of a published article. This report referred to a male patient of unknown age with recurrent respiratory papillomatosis and pulmonary involvement. The patient's initial diagnosis was made during infancy when bronchoscopy for hoarseness revealed airway papilloma. He had extensive laryngeal involvement with significant scarring of the larynx from multiple debridements, which also resulted in an unrecognizable left arytenoid and vocal cord. At two years of age, worsening airway obstruction led to a tracheostomy at an outside institution and two years later, the patient had laryngotracheoplasty with decannulation. The patient continued to have multiple debridements with a microdebrider every 6-8 weeks. On an unknown date the patient was vaccinated with intralesional injection of mumps vaccine (unspecified, manufacture unknown) (strength, dose detail, lot # and expiration date were not reported) for recurrent respiratory papillomatosis. As it reported, the patient has no improvement. Pulmonary parenchymal involvement was discovered on chest computed tomography (CT) at 13 years of age. Two months prior to referral, pulmonary function declined with FEV1/FVC 74% from his baseline of 90-100% and flattening of his inspiratory flow loop. Exam revealed a prolonged inspiratory phase, clear breath sounds and productive cough. Azithromycin three times a week, mometasone/formoterol and levalbuterol were continued and airway clearance initiated. Discussion between pulmonology, otorhinolaryngology, infectious disease and oncology led to a trial of systemic bevacizumab which was initiated at 10 mg/kg intravenously (IV) every 3 weeks for 3 months. Repeat chest CT scan after 3 months showed resolution of his pulmonary nodule within the anterior segment of the left lower lobe and no new lesions. No airway debridement was required until 6 months after initiation of bevacizumab. The patient then underwent a left endoscopic partial arytenoidectomy for worsening dyspnea on exertion, resulting in improvement of his breathing and spirometry.
Sex: M
Vaccine: MMR, MMRV
Symptoms: Peak nasal inspiratory flow abnormal, Product use in unapproved indication, Productive cough, Respiratory papilloma, Spirometry
Clinical narrative: This literature market report has been received from authors of a published article. This report referred to a male patient of unknown age with recurrent respiratory papillomatosis and pulmonary involvement. The patient's initial diagnosis was made during infancy when bronchoscopy for hoarseness revealed airway papilloma. He had extensive laryngeal involvement with significant scarring of the larynx from multiple debridements, which also resulted in an unrecognizable left arytenoid and vocal cord. At two years of age, worsening airway obstruction led to a tracheostomy at an outside institution and two years later, the patient had laryngotracheoplasty with decannulation. The patient continued to have multiple debridements with a microdebrider every 6-8 weeks. On an unknown date the patient was vaccinated with intralesional injection of mumps vaccine (unspecified, manufacture unknown) (strength, dose detail, lot # and expiration date were not reported) for recurrent respiratory papillomatosis. As it reported, the patient has no improvement. Pulmonary parenchymal involvement was discovered on chest computed tomography (CT) at 13 years of age. Two months prior to referral, pulmonary function declined with FEV1/FVC 74% from his baseline of 90-100% and flattening of his inspiratory flow loop. Exam revealed a prolonged inspiratory phase, clear breath sounds and productive cough. Azithromycin three times a week, mometasone/formoterol and levalbuterol were continued and airway clearance initiated. Discussion between pulmonology, otorhinolaryngology, infectious disease and oncology led to a trial of systemic bevacizumab which was initiated at 10 mg/kg intravenously (IV) every 3 weeks for 3 months. Repeat chest CT scan after 3 months showed resolution of his pulmonary nodule within the anterior segment of the left lower lobe and no new lesions. No airway debridement was required until 6 months after initiation of bevacizumab. The patient then underwent a left endoscopic partial arytenoidectomy for worsening dyspnea on exertion, resulting in improvement of his breathing and spirometry.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report has been received from a Rheumatologist, via Pfizer (Manufacturer Report Number 2018278171), concerning a currently 69 years old female patient. The patient's concurrent conditions included allergy to sulfa and hydroxychloroquine, and rheumatoid arthritis. The patient's historical drugs included ENBREL and other unspecified therapies (Illegible information). The patient's concomitant therapies included XELJANZ and RHEUMATREX. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (concentration, dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX 23. At the time of reporting, the patient's outcome for allergy to vaccine was unknown. The causal relationship between PNEUMOVAX 23 and the event was assessed as related.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: Information has been received from a female consumer, referring to a currently 21 year old daughter. Information of concurrent condition, medical history and concomitant therapy was not provided. In 2013 (the patient's age of 16), the patient was vaccinated with GARDASIL for prophylaxis (dose, strength, lot# and expiration date unknown). The patient was unsure whether she got subsequent shots.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date the patient received an unspecified dose of PNEUMOVAX 23 (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis and had significant arm swelling and fever for two days. The outcome of the events was reported as unknown. The causality between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 29-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 05-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA001261; US-009507513-1808USA004401.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 10-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 10-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 11-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 11-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case: 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 13-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA001261: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261;  US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA001261; US-009507513-1808USA004401.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 16-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261z US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261 US-009507513-1808USA004371.