chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Received call from patient asking for assistance in treating the following and spoke with patient on his reaction: 39 YO adult male received 2nd AVA vaccine on 2/3/2017. No other vaccines given since 12/29/2017 (AVA1 and VAR). Patient is deploying overseas on 2/25/17. 2/3/2017 patient reported had burning sensation to left arm, similar to first AVA vaccine, with receipt of 2nd AVA vaccination. Next day (Sat. 2/4 evening) his deltoid was hot, red and painful. Redness covered about 1/2 of arm (anterior portion only, did not encircle arm). He reported he had a mild fever day of vaccination, but none on Saturday or since. He advised he had some diffuse joint pain to shoulders and lower back, but has history of back/neck pain. He presented to medical today 2/6 at Clinic with swelling, redness and patient describing upper anterior arm/deltoid as red, warm, and deltoid was hard to touch/indurated with redness extending down to mid humerus close to elbow. No paresthesia, weakness, tingling or restricted ROM in shoulder/elbow. No fever or rash. No axillary lymphadenopathy. No chest pain, headache, difficulty breathing or other systemic symptoms. Symptoms: Localized edema, other skin changes.
Age: 41.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Localised oedema, Rash
Clinical narrative: 2/17/2017 1200 hr: Received direct call from clinic and spoke directly with patient. Pt reports received varicella #2 to left tricep region on 2/15/2017. Over last two days the area is red, painful and itching. She denies any fever, n/v/weakness to her fingers, elbow, and no limitation in ROM to her arm. Clinic confirms reaction about 6cm circular in duration. (Vaccines given as part of nursing school requirements - Var Titer 10/15/2015 was negative.) Localized edema, rash and oth nonspec skin eruption.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site papule, Injection site swelling, Injection site warmth
Clinical narrative: The 11 year old F presents with mom for reactions following recent vaccinations. On 2/24/2017 she received routine school required vaccinations (for 4th grade). She received Men vaccine (NOV lot#M15164) to right deltoid and BOOSTRIX (Lot #E7GM7) to left deltoid. Band-aids were applied. The next day she noted some redness under the left arm Band-Aid that continued to progress to current warm red, swollen area. They saw their HCP who referred to provider for further evaluation of this site reaction. Exam: General appearance was normal. Mobile. Texture was normal. Turgor was normal. Color and pigmentation were normal. Moisture was normal. Temperature was normal. Injection Site: Assessment on the right arm showed abnormalities Child had multiple single red papules in shape of Band-Aid to right deltoid over where MEN vaccine given 2.5x5 cm size. Otherwise skin normal, no axillary lymphadenopathy, weakness or limitations to in right arm/shoulder ROM. Assessment on the left arm showed abnormalities Child with total of 10x5cm trapezoid shaped slightly warm, red shaped area surrounding and just under Tdap vaccine site. Within this site was a 2.5x5 cm bandaid shape impression to top portion of this region that had multiple single red papules. Not itchy. There was 1 mobile axillary lymph node and no restriction in ROM to left arm/shoulder and no Paraesthesia, no weakness. Rash and oth nonspec skin eruption.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Rash/redness left arm 3 days after imms. Pain at site night of and next day. All Sx resolved 3-12-17.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash around the site of injection, now resolving on its own.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, Red , Warm, Swollen area on right posterior side of upper arm (between elbow and shoulder) , effected area measured 145 mm in L x 140 mm in W, more solid and differently colored center of effected area measured 35 mm L x 55 mm W, began with discomfort while sleeping the night after receiving it, the next day it warm and red, 2nd morning after vaccine area presented as documented above.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt did not have any adverse events. Wrong vaccine administered. Pt received PROQUAD vaccine and varicella vaccine.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt stated: 7/10 pain in entire right shoulder and down her arm. Tingling and numbness in her fingers (pinky, ring, and middle finger.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 71-year-old male patient. There was no information about the patient concurrent conditions, concomitant therapies or medical history provided. On 24-FEB-2017, the patient was inadvertently vaccinated with an expired single dose of PNEUMOVAX23 injection (lot # L024132 with an expiration date of 21-JAN-2017) intramuscularly for prophylaxis (anatomical location was not reported). There was no adverse effect reported. There was no product quality complaint involved. Additional information is not expected because there was consent to contact with the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the VAQTA (lot number M016191, expiration date 26-MAY-2017, lot number M011116, expiration date 01-JUN-2017) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007375: US-009507513-1703USA007373: US-009507513-1703USA007374: US-009507513-1703USA007371: US-009507513-1703USA007372:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 06-MAR-2017 from a vaccine coordinator regarding an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient may have been vaccinated with a dose of ROTATEQ lot # M017518, expiration 11-DEC-2017, oral for prophylaxis which was improperly stored. The vaccine was stored in the temperature range of 47 degrees F to 77 degrees F for 10 minutes. Call was due to a data logger. No adverse effect was reported. No additional information was provided. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site induration, Injection site reaction, Rash
Clinical narrative: This is a spontaneous report received from a female consumer with allergy to FLAGYL who received a dose of ZOSTAVAX on 07-MAR-2017 intramuscularly, for the prevention of shingles. Concomitant medication included SYNTHROID 150 mg, simvastatin 10 mg, vitamins (unspecified) and probiotics (unspecified). The patient reported that she is experiencing an injection site reaction. It is bright red, hard, and sensitive. She also stated that she has a slight rash on both arms. No treatment was received and the patient did not seek medical attention. The outcome of these events was reported as 'not recovered'. The causality was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a office manager and refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 09-MAR-2017, the patient was vaccinated with M-M-R II, a single dose, lot number M028131, expiration date 03-JUN-2018, by subcutaneous route, (anatomical location and dose number were not reported), for prophylaxis. On the same date, the patient was inadvertently administered a dose of PROQUAD .No adverse effects reported. No product quality complain was involved.  Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2012, the patient was inadvertently administered, due to human error, a dose of VAQTA lot # H012642 for prophylaxis (dose, rote and expiration date were not reported). The reporting nurse stated that the patient was to have received an unspecified hepatitis B vaccine (manufacturer unknown) not the VAQTA on that date. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the RECOMBIVAX HB (lot number L042846, expiration date 15-SEP-2017, lot number M028322, expiration date 31-MAY-2018, lot number M018645, expiration date 31-MAY-2018, lot number L040458, expiration date 04-FEB-2018, lot number L048849, expiration date 04-FEB-2018) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder than 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA007375: US-009507513-1703USA007373: US-009507513-1703USA007374: US-009507513-1703USA001520: US-009507513-1703USA007372.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the GARDASIL (lot number K016966, expiration date 10-MAY-2017, lot number L035105, expiration date 14-MAY-2017, lot number M014929, expiration date 27-MAY-2017) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA007375: US-009507513-1703USA007373: US-009507513-1703USA007374: US-009507513-1703USA007371: US-009507513-1703USA001520.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the ROTATEQ (lot number K016966, expiration date 16-JUN-2017) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients.  From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported.   Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007375: US-009507513-1703USA001520: US-009507513-1703USA007374: US-009507513-1703USA007371: US-009507513-1703USA007372:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the PNEUMOVAX 23 lot number M039060, expiration date 22-MAY-2018 (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA007375: US-009507513-1703USA007373: US-009507513-1703USA001520: US-009507513-1703USA007371: US-009507513-1703USA007372.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the GARDASIL 9 (lot number L019297, expiration date 18-AUG-2017, lot number M023169, expiration date 13-JUN-2018) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients.  From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported.   Additional information has been requested.; Sender's Comments:  US-009507513-1703USA001520: US-009507513-1703USA007373: US-009507513-1703USA007374: US-009507513-1703USA007371: US-009507513-1703USA007372:
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Viral upper respiratory tract infection
Clinical narrative: Pain at site of injection cold symptoms headaches. (lasted 1 hr).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Confusional state, Fatigue, Hypersomnia, Social avoidant behaviour
Clinical narrative: My son was extremely tired and slept most of the day following his shot, 6.5 hours versus 2.5 for naps. During his period of being awake he would stare off no where. He stopped engaging with people. He stopped smiling. He looked at his toys confused. He continues to tap his finger tips together. He doesn't respond to his father or I when we greet him. He is no longer soothed when we hold him. He doesn't cry much; he just seems empty. He stares at the ceiling or sometimes his mobile spinning around.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: My son was extremely tired and slept most of the day following his shot, 6.5 hours versus 2.5 for naps. During his period of being awake he would stare off no where. He stopped engaging with people. He stopped smiling. He looked at his toys confused. He continues to tap his finger tips together. He doesn't respond to his father or I when we greet him. He is no longer soothed when we hold him. He doesn't cry much; he just seems empty. He stares at the ceiling or sometimes his mobile spinning around.
Age: 31.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash erythematous
Clinical narrative: Red rash 10-15 cm in width at its widest point, below site of injection with TRUMENBA and Hepatitis B vaccinations, lasted 3-4 days.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 03/15/2017 3:30PM-4:00PM CHILD COMPLAINS OF PAIN TO RIGHT ARM.  THERE WAS SWELLING TO UPPER RIGHT ARM AND TO THE INJECTION SITE,  LOW GRADE FEVER OF 99.8 F AND BANDAID WAS SATURATED WITH BLOOD.  4:30PM-4:45PM MOTHER CALLED HOSPITAL AND ADVISED TO CHANGE THE BANDAID.  5:00PM THE CHILD BECAME LETHARGIC AND NOT TALKING.  MOTHER TRANSPORTED THE CHILD TO HOSPITAL.  MOTHER REPORTS OBSERVED A RASH TO THE CHILD'S ARMS AND HANDS AT TIME OF TRANSPORT.  SHE DESCRIBED THE RASH AS A RED, BLOTCHY AND RAISED RASH WITH SWELLING TO THE HANDS.  TYLENOL WAS GIVEN AT 5:00PM BEFORE LEAVING FOR THE HOSPITAL.  CHILD WAS GIVEN BENADRYL AT 6:30PM AND MOTRIN AT 7:00PM WHILE BEING EVALUATED IN THE ER.  MOTHER REPORTS THE RASH WAS BEGINNING TO DIMINISH AT 9:30PM.  03/16/2017 3:00PM RECEIVED A TELEPHONE CALL FROM CHILD'S MOTHER TO REPORT THE SYMPTOMS HER SON EXPERIENCED AFTER RECEIVING IMMUNIZATIONS AT THE HEALTH DEPARTMENT THE PREVIOUS DAY AND TAKING CHILD TO THE ER FOR MANAGEMENT OF THE SYMPTOMS.  MOTHER STATES THE RASH IS RESOLVED AND CHILD STILL COMPLAINS OF PAIN TO UPPER RIGHT ARM AND TENDER TO TOUCH TO THE SITE OF THE INJECTION. SHE ALSO REPORTS THERE IS NO DRAINAGE TO THE SITE, BUT THERE IS A BRUISE LIKE DISCOLORATION AND MILD SWELLING.  THE CHILD ALSO DOES NOT HAVE A FEVER.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Lethargy, Peripheral swelling, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: 03/15/2017 3:30PM-4:00PM CHILD COMPLAINS OF PAIN TO RIGHT ARM.  THERE WAS SWELLING TO UPPER RIGHT ARM AND TO THE INJECTION SITE,  LOW GRADE FEVER OF 99.8 F AND BANDAID WAS SATURATED WITH BLOOD.  4:30PM-4:45PM MOTHER CALLED HOSPITAL AND ADVISED TO CHANGE THE BANDAID.  5:00PM THE CHILD BECAME LETHARGIC AND NOT TALKING.  MOTHER TRANSPORTED THE CHILD TO HOSPITAL.  MOTHER REPORTS OBSERVED A RASH TO THE CHILD'S ARMS AND HANDS AT TIME OF TRANSPORT.  SHE DESCRIBED THE RASH AS A RED, BLOTCHY AND RAISED RASH WITH SWELLING TO THE HANDS.  TYLENOL WAS GIVEN AT 5:00PM BEFORE LEAVING FOR THE HOSPITAL.  CHILD WAS GIVEN BENADRYL AT 6:30PM AND MOTRIN AT 7:00PM WHILE BEING EVALUATED IN THE ER.  MOTHER REPORTS THE RASH WAS BEGINNING TO DIMINISH AT 9:30PM.  03/16/2017 3:00PM RECEIVED A TELEPHONE CALL FROM CHILD'S MOTHER TO REPORT THE SYMPTOMS HER SON EXPERIENCED AFTER RECEIVING IMMUNIZATIONS AT THE HEALTH DEPARTMENT THE PREVIOUS DAY AND TAKING CHILD TO THE ER FOR MANAGEMENT OF THE SYMPTOMS.  MOTHER STATES THE RASH IS RESOLVED AND CHILD STILL COMPLAINS OF PAIN TO UPPER RIGHT ARM AND TENDER TO TOUCH TO THE SITE OF THE INJECTION. SHE ALSO REPORTS THERE IS NO DRAINAGE TO THE SITE, BUT THERE IS A BRUISE LIKE DISCOLORATION AND MILD SWELLING.  THE CHILD ALSO DOES NOT HAVE A FEVER.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphagia, Joint stiffness, Muscle spasms, Myalgia
Clinical narrative: Painful muscle spasms/stiffness in jaw. Some swallowing problems.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within a few hours of injection site was very sore.  Within in 24 hours painful area on arm expanded.  Within 48 hours 4 inches medially and below had swelling, redness, and warm skin.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates in 2014 (reported as "about three years ago"), the patient was vaccinated with the first and second doses of GARDASIL (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. On 17-FEB-2017 (reported as "currently"), the patient was in the office to receive a third dose of the human papillomavirus (HPV) series in which GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were unknown) would be administered for the same indication. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female patient in her 60's. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On 10-MAR-2017, the patient went to the pharmacy for a dose of ZOSTAVAX. Reportedly, the patient had an active case of shingles at that time, which started from an unspecified date. The patient's outcome and the causality assessment between ZOSTAVAX and herpes zoster were not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Pruritus, Rash macular
Clinical narrative: Patient has a "red splotch" at the site of his MCV injection. Shortly after vaccination was administered on 3/7/17, the arm appeared red and became itchy. There is a black dot where the injection pierced the skin. On 3/9 in the evening the area of redness was 3-4" in diameter and mom gave BENADRYL then as well as in the AM of 3/10 because patient was c/o itching.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient develeoped mild shingles rash on back.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient develeoped mild shingles rash on back.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse events. No symptoms, problems or treatments.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Apnoea, Bradycardia, Endotracheal intubation, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: Baby had vaccines on 3/11/17 and the next morning began having significant apnea/brady/desat episodes and visible seizures eventually requiring resuscitation and intubation.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Resuscitation, Seizure
Clinical narrative: Baby had vaccines on 3/11/17 and the next morning began having significant apnea/brady/desat episodes and visible seizures eventually requiring resuscitation and intubation.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: THIS NURSE REALIZED WHEN CHARTING VACCINE THAT WRONG VACCINE HAD BEEN ADMINISTERED TO PATIENT.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Crohn's disease, Diarrhoea haemorrhagic, Pyrexia, Vomiting
Clinical narrative: Approximately 12 hours after receiving Tdap patient reported a flare of her Crohn's disease.  She reported bloody diarrhea, vomiting.  At 24 hrs after the vaccine she noted a fever of 103. Her PCP Dr advised patient to call back if not starting to improve by the afternoon of 3/16/17. At the time of this report 5:05PM we had not heard from patient.  A message was left to check on patient and asked her to call back with an update.
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: Upper Arm serious pain when I move my arm in certain directions. It gets worse with time.
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: Upper Arm serious pain when I move my arm in certain directions. It gets worse with time.
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Upper Arm serious pain when I move my arm in certain directions. It gets worse with time.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at reaction site.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Life support, Lung disorder, Renal impairment, X-ray
Clinical narrative: Right lung shut down, was put on life support, renal function critical level.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Aphasia, Eye movement disorder, Gaze palsy, Seizure like phenomena, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of upward deviation of eyes in a 3-year-old male patient who received ENGERIX B Pediatric (batch number 44DF2, expiry date 25th May 2018). Concomitant products included SINGULAIR. On 5th January 2017, the patient received the 1st dose of ENGERIX B Pediatric .5 ml. On 7th January 2017, 2 days after receiving ENGERIX B Pediatric, the patient experienced upward deviation of eyes (serious criteria GSK medically significant) and tremor. On an unknown date, the outcome of the upward deviation of eyes and tremor were recovered/resolved. It was unknown if the reporter considered the upward deviation of eyes and tremor to be related to ENGERIX B Pediatric. Additional details were provided as follows: The patient received ENGERIX B Pediatric on a Thursday. On the Saturday, the patient experienced a seizure like symptoms. He was shaking, his eyes rolled back in his head and he did not speak for 20 minutes.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dehydration, Dizziness, Influenza, Staphylococcal infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included ADVAIR DISKUS inhalation powder (batch number 6ZP7785, expiry date 31st January 2018) for chronic obstructive pulmonary disease. In September 2016, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR DISKUS (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In December 2016, 91 days after receiving Influenza vaccine Quadrivalent and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), methicillin-resistant staphylococcus aureus infection (serious criteria hospitalization and GSK medically significant), dehydration (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On an unknown date, the patient experienced weakness. ADVAIR DISKUS was continued with no change. On an unknown date, the outcome of the vaccination failure and weakness were unknown and the outcome of the influenza, dehydration and dizziness were recovered/resolved and the outcome of the methicillin-resistant staphylococcus aureus infection was recovering/resolving. The reporter considered the vaccination failure and influenza to be possibly related to Influenza vaccine Quadrivalent. The reporter considered the methicillin-resistant staphylococcus aureus infection, dehydration and dizziness to be unrelated to Influenza vaccine Quadrivalent and ADVAIR DISKUS. It was unknown if the reporter considered the weakness to be related to Influenza vaccine Quadrivalent. and ADVAIR DISKUS. The reporter considered the influenza to be unrelated to ADVAIR DISKUS. Additional details were provided as follows: The case was previously reported to the physician. In 2012, the patient received ADVAIR DISKUS. The manufacturer for influenza injection was unknown. In December 2016, approximately 4 years after receiving ADVAIR DISKUS and approximately 3 months after receiving Influenza vaccine Quadrivalent, the patient experienced influenza, methicillin-resistant staphylococcus aureus infection, dehydration and dizziness. The patient was hospitalized for a day and a half. The patient was discharged, but went back in the hospital one week later. On his previous hospital stay, he contracted methicillin-resistant staphylococcus aureus infection (MRSA). The patient was transferred to a different hospital for several days. The patient reported that the methicillin-resistant staphylococcus aureus infection (MRSA) was finally killed off, but it left him weak. The patient did not recall the name of the physician, he had, but said fine to receive a letter asking for that information. He had the paperwork somewhere. This case was considered as suspected vaccination failure as the lab test confirmation was unknown at the time of reporting.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included ADVAIR DISKUS inhalation powder (batch number 6ZP7785, expiry date 31st January 2018) for chronic obstructive pulmonary disease. In September 2016, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR DISKUS (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In December 2016, 91 days after receiving Influenza vaccine Quadrivalent and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), methicillin-resistant staphylococcus aureus infection (serious criteria hospitalization and GSK medically significant), dehydration (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On an unknown date, the patient experienced weakness. ADVAIR DISKUS was continued with no change. On an unknown date, the outcome of the vaccination failure and weakness were unknown and the outcome of the influenza, dehydration and dizziness were recovered/resolved and the outcome of the methicillin-resistant staphylococcus aureus infection was recovering/resolving. The reporter considered the vaccination failure and influenza to be possibly related to Influenza vaccine Quadrivalent. The reporter considered the methicillin-resistant staphylococcus aureus infection, dehydration and dizziness to be unrelated to Influenza vaccine Quadrivalent and ADVAIR DISKUS. It was unknown if the reporter considered the weakness to be related to Influenza vaccine Quadrivalent. and ADVAIR DISKUS. The reporter considered the influenza to be unrelated to ADVAIR DISKUS. Additional details were provided as follows: The case was previously reported to the physician. In 2012, the patient received ADVAIR DISKUS. The manufacturer for influenza injection was unknown. In December 2016, approximately 4 years after receiving ADVAIR DISKUS and approximately 3 months after receiving Influenza vaccine Quadrivalent, the patient experienced influenza, methicillin-resistant staphylococcus aureus infection, dehydration and dizziness. The patient was hospitalized for a day and a half. The patient was discharged, but went back in the hospital one week later. On his previous hospital stay, he contracted methicillin-resistant staphylococcus aureus infection (MRSA). The patient was transferred to a different hospital for several days. The patient reported that the methicillin-resistant staphylococcus aureus infection (MRSA) was finally killed off, but it left him weak. The patient did not recall the name of the physician, he had, but said fine to receive a letter asking for that information. He had the paperwork somewhere. This case was considered as suspected vaccination failure as the lab test confirmation was unknown at the time of reporting.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Allergy test negative, Erythema, Peripheral swelling, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 12-year-old female patient who received MENVEO. On 20th April 2012, the patient received the 1st dose of MENVEO (intramuscular). On 20th April 2012, less than a day after receiving MENVEO, the patient experienced swelling arm (serious criteria hospitalization), pruritus (serious criteria hospitalization) and erythema (serious criteria hospitalization). On an unknown date, the outcome of the swelling arm, pruritus and erythema were unknown. It was unknown if the reporter considered the swelling arm, pruritus and erythema to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO in an unknown arm. On the next day after vaccination, the patient's whole arm was affected. The patient was taken to the emergency room (ER) and was initially diagnosed with cellulitis. The patient was admitted to the hospital and cellulitis was ruled out. It was decided to be a reaction to the MENVEO vaccine. The patient had not received any further MENVEO injections, but college was requiring her to be vaccinated before attending, so they are trying to determine what she reacted to. The patient was tested for an allergy to formaldehyde, but that was found negative. The batch number information was unknown. The reporter denied permission to contact the physician.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13
Symptoms: Dermatitis, Rash generalised, Rash macular, Urticaria
Clinical narrative: Generalized exanthem with onset 24-30 hours after receipt of 12 month vaccines (IIV SKB lot #UT5691NA), MMR (MO15930) PREVNAR (Wyeth R41774), varicella (Merck M039905) on 22 FEB 2017. She states at about 30 hours post vaccine, she was notified by the day care when she picked him up to inspect a dermatitis that had been noted during the day. She states it was generalized including abdomen, legs, hands and neck, erythematous, flat macular. She denies vesicles, papules or pustules. She denies observing pruritus. He has no systemic symptoms and seemed otherwise well. She states she took him to ER and they thought it was hives and he was treated with 7 days of prednisone and ZYRTEC. There was no oral/facial/throat or tongue swelling, flushing, conjunctivitis, wheezing, cough, SOB, nausea or emesis. The dermatitis cleared at 7 days except the abdomen which cleared at 8 days.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash in left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling and itching noticed morning of 3/16/17.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Urticaria
Clinical narrative: Pt waiting for 15 minutes. When checked pt welt measuring 1in. x 5in. Pt was given 5 ml of BENADRYL in our office and waited for 30 minutes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Pain
Clinical narrative: 3/13 - vaccine 3/13. 3/15 - noted redness over vaccine sites R thigh ant Lat. C/O pain, no fever. 3/16 seen at clinic, Less erythema.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt says that the sore on his arm was from the flu shot, but it is not in the correct spot. I believe wing of Bandaid pulled off some skin and made the sore, but pt believes otherwise. Unable to reach for more details.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccination at approximately 3:30pm. Immediately after, the injection site began to swell and became hard and hot to the touch. Pt was monitored for about an hour. She was given no meds. Pt left with minor swelling about 1 hours after shot.
Age: 43.0
Sex: M
Vaccine: FLU3, FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Muscular weakness, Sleep disorder
Clinical narrative: C/O Shoulder pain and limited ROM.
Age: 43.0
Sex: M
Vaccine: FLU3, FLUC4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: C/O Shoulder pain and limited ROM.
Age: 0.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cyanosis, Eye movement disorder, Musculoskeletal stiffness, Seizure
Clinical narrative: Seizure activity-stiffening of bilateral arms and legs, eyes rolling in back of head, periorbital cyanosis lasting 60-90 seconds; unknown temp-1.5hours after motrin given, T-100.3 rectally.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: The area were the vaccine was administered became swollen, reddish and itchy.  The course was about 4 hours.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a licensed practical nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unspecified date, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M006107, expiration date 01-AUG-2017 (dosage and route of administration not provided). The information was received because of a data logger. Temperature/Time frame: -14°C to -10°C for 1 hour, 36 minutes. No previous temperature excursion. Additional information has been requested.
Age: 0.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: No adverse event, Wrong patient received medication
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 4-day-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 13-MAR-2017, the patient was mistakenly given a dose of ROTATEQ orally, lot# reported as M042172, expiration date 08-JUN-2018 (dose was not provided). The vaccine was intended for a different patient in a different exam room. No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 4-day-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 13-MAR-2017, the patient was mistakenly given a dose of ROTATEQ orally, lot# reported as M042172, expiration date 08-JUN-2018 (dose was not provided). The vaccine was intended for a different patient in a different exam room. No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unspecified gender. On 13-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L009213 exp date 17-MAR-2017) (dose and route not reported). The temperature of excursion was 47 °F to 77 °F with a highest temperature of 55.1 °F for 15 minutes. There was no previous temperature excursion. A data logger issue was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007644.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored VARIVAX (lot # reported as M015731, expiration date 27-OCT-2017; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, duration of temperature excursion): 26-NOV-2016, 6 degree Fahrenheit (F), 6 min 26-NOV-2016, 7 F, 6 min 26-NOV-2016, 8 F, 6 min 26-NOV-2016, 9 F, 9 min 26-NOV-2016, 10 F, 4 min 25-NOV-2016, 6 F, 10 min 24-NOV-2016, 6 F, 8 min 24-NOV-2016, 7 F, 6 min 13-NOV-2016, 7 F, 8 min 13-NOV-2016, 6 F, 7 min 12-NOV-2016, 6 F, 10 min 12-NOV-2016, 7 F, 7 min 12-NOV-2016, 8 F, 10 min 06-NOV-2016, 6 F, 8 min 06-NOV-2016, 7 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 6 F, 6 min 04-NOV-2016, 7 F, 6 min 04-NOV-2016, 8 F, 7 min 04-NOV-2016, 6 F, 6 min Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source.    Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored ZOSTAVAX (lot # M033910, expiration date 17-OCT-2017; lot # M018593, expiration date 28-JUN-2017) was stored in the temperature of between 5 and 14 degrees Fahrenheit for 142 minutes, with no previous temperature excursion; dose and route not reported) for prophylaxis. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989.
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored GARDASIL (also reported as GARDASIL 9) lot # M026306, expiration date 30-APR-2019; lot # M021407, expiration date 30-APR-2018; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, Duration of temperature excursion): lot # L017757, expiration date 08-APR-2018; lot # L017757, expiration date 08-APR-2018: 02-NOV-2016, 47 degree Fahrenheit (F), 25 min 02-NOV-2016, 48 F, 20 min 02-NOV-2016, 34 F, 91 min 03-NOV-2016, 34 F, 115 min 11-NOV-2916, 34 F, 1 min 13-NOV-2016, 34 F, 38 min 13-NOV-2016, 33 F, 35 min 14-NOV-2016, 34 F, 350 min 14-NOV-2016, 33 F, 240 min 15-NOV-2016, 33 F, 111 min 15-NOV-2016, 34 F, 307 min 14-NOV-2016, 33 F, 112 min 14-NOV-2016, 34 F, 212 min lot # M021407, expiration date 30-APR-2018: 01-NOV-2016, 32 F, 1 min 01-NOV-2016, 33 F, 37 min 01-NOV-2016, 34 F, 51 min 01-NOV-2016, 35 F, 148 min 02-NOV-2016, 34 F, 15 min 02-NOV-2016, 35 F, 110min 03-NOV-2016, 34 F, 4 min 03-NOV-2016, 35 F, 127 min 04-NOV-2016, 35 F, 96 min 04-NOV-2016, 34 F, 3 min 05-NOV-2016, 35 F, 105 min 04-NOV-2016, 35 F, 81 min Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L014878, expiration date 17-JAN-2018; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, Duration of temperature excursion): 1612 minutes 02-NOV-2016, 47 degree Fahrenheit (F), 25 min 02-NOV-2016, 48 F, 20 min 02-NOV-2016, 34 F, 91 min 03-NOV-2016, 34 F, 115 min 11-NOV-2916, 34 F, 1 min 13-NOV-2016, 34 F, 38 min 13-NOV-2016, 33 F, 35 min 14-NOV-2016, 34 F, 350 min 14-NOV-2016, 33 F, 240 min 15-NOV-2016, 33 F, 111 min 15-NOV-2016, 34 F, 307 min 14-NOV-2016, 33 F, 112 min 14-NOV-2016, 34 F, 212 min. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored PNEUMOVAX23 lot# M022947, expiration date 12-NOV-2017; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, Duration of temperature excursion): 02-NOV-2016, 47 degree Fahrenheit (F), 25 min 02-NOV-2016, 48 F, 20 min 02-NOV-2016, 34 F, 91 min 03-NOV-2016, 34 F, 115 min 11-NOV-2916, 34 F, 1 min 13-NOV-2016, 34 F, 38 min 13-NOV-2016, 33 F, 35 min 14-NOV-2016, 34 F, 350 min 14-NOV-2016, 33 F, 240 min 15-NOV-2016, 33 F, 111 min 15-NOV-2016, 34 F, 307 min 14-NOV-2016, 33 F, 112 min 14-NOV-2016, 34 F, 212 min. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007063: US-009507513-1703USA000989: