chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 17-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 12-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 12-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 10-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 06-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 16 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 12-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 13 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: Pateint received improperly stored HPV vaccine; This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) lot # N000326, expiration date 14-OCT-2019 or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1709USA008666:
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: 12 hours after the vaccine, his arm became swollen, hot, hard and red from the shoulder to the elbow. His Mom took him to Urgent care and they told her to give him CLARITIN. We spoke on 10/24/17 and the arm was no longer hard but was still warm and red. Mom is to consult with her pediatrician about next year's flu vaccine. I sent her the package insert.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site swelling, Injection site erythema
Clinical narrative: Red, swollen admin site.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. The pharmacist reported that on 23-OCT-2017 the patient was inadvertently vaccinated with expired dose of ZOSTAVAX 19400 PFU (lot # M033910, Expiry date: 17-OCT-2017) for prophylaxis. Concomitant therapies included sterile diluent (Lot # M004656, Expiry date: 13-AUG-2018). No adverse event reported. There was no product quality complaint involved. Sender's Comments: US-009507513-1710USA014683.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Respiratory disorder
Clinical narrative: Child was leaving health unit with mother and when she got out to their vehicle, the grandmother noticed the red streak on child's left arm and told the mother: mother and child immediately came back into the unit and notified clerical staff, who notified the nurse. Redness about 1/2 to 1 inch in width from left deltoid area down to wrist, child's hands puffy, child denied any difficulty breathing, lung fields auscultated, BS clear. I looked at arm again and noted 2 small whelps on lower inner arm above wrist and 3 small hives on right side of face near corner of the mouth; asked mother who PCP was, mom stated clinic (15 miles away) phone call made to local MD office to see if MD/APRN could evaluate child now. Suggested to family that EMS be called to come take child to ER and grandfather stated he could drive there faster, we encouraged them not to drive on their own as other problems could occur. APRN at clinic agreed to evaluate child. Mother called back about an hour later and reported child did begin to have respiratory issues after getting to medical clinic, child received steroid shot and BENADRYL and stated child is doing better and are on their way home. Instructed mother to watch for any other S&S and to take child to ER. TC called at 1530 to see how child was doing mother states doing fine. Mother states APRN prescribed Prednisone but forgot to get it filled, told mom to give child more BENADRYL in 4 hours and to get RX filled.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Diarrhea, aches, slight fever for the first 2 days, now vomiting and headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Child had swelling from right elbow up to his shoulder. Father took child to Dr, who diagnosed child with cellulitis due to the injection. He was placed on antibiotics. Dad was contacted after antibiotic treatment was completed and he stated child was doing well.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Headache, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Flushing and arm stiff and painful. Progressed to stiffness in neck, severe headache and nausea, faint.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Flushing and arm stiff and painful. Progressed to stiffness in neck, severe headache and nausea, faint.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Body temperature increased, Fatigue, Headache, Malaise
Clinical narrative: Joint pain, fatigue, malaise, increased temperature, headache.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Pyrexia
Clinical narrative: Severe chills, fever of 103.3 first night- followed by fever of over 101 for next 2 days.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Redness, swelling, lump, warm to touch.
Age: 11.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Redness, swelling, lump, warm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Severe chills, fever of 103.3 first night- followed by fever of over 101 for next 2 days.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site pain
Clinical narrative: PT STATES THAT HE WOKE UP ON SATURDAY (<24 HOURS) FROM RECEIVING VACCINE WITH MILD ITCHING ON RIGHT ARM THAT PROGRESSED TO SWELLING, ITCHING, AND REDNESS REACHING ALMOST TO THE ELBOW JOINT. PAIN AT 2/10 AT THE VACCINATION SITE BUT NOWHERE ELSE. NO TENDERNESS TO PALPATION AND FULL RANGE OF MOTION TO ELBOW/SHOULDER. GOING TO ER FOR FURTHER CARE.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash, employee states she took BENADRYL PO, symptoms resolved.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Employee stated 4-5hrs after receiving vaccine she begin to feel dizzy, lightheaded. Symptoms progressed to fever, nausea and vomiting on Thursday & Friday, vomited x 3, fever subsided Friday night, vomited x 1 on Saturday. States she is to be seen by her PCP on Tuesday (10/31/17). Feels better today, no other symptoms noted.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Annual Influenza Immunization. My symptoms are numbness in lips and finger and throbbing headache. About 4pm and ongoing on and off since flu shot.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Redness, swelling, lump, warm to touch.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: After 5 minutes of vaccination, patient fainted for a few seconds.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt. stated she had red bumpy rash like area on back portion of (L) arm.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin abnormal, Ultrasound antenatal screen abnormal
Clinical narrative: It was a flu shot, but I'm not sure what kind. I know it was not preservative free because I declined a preservative free shot, and I don't think it was quadrivalent. I was 3 weeks 1 day pregnant, EDD 5/30/2018. Miscarriage began 9/23/2017 and was confirmed by hCG draws and ultrasound.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient fainted, has history of fainting.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at left shoulder after receiving pneumonia and influenza shot two days prior to admission. Both vaccines where administered at the same day and at the same site. Erythema and edema to left shoulder.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dyspnoea, Flushing, Pyrexia, Rash
Clinical narrative: As soon as got flu shot about 10 min later had tachycardia, flushing and tactile fever. Subjective SOB,  lump in throat, and hives on neck and face. Confusion. Lasted until the next day. Took Benadryl. Around midnight symptoms returned. Was scheduled to work Saturday, but was unable to do it. Symptoms were resolved by Sunday. Rash alsoresolved. Now 100% better.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Tachycardia, Urticaria
Clinical narrative: As soon as got flu shot about 10 min later had tachycardia, flushing and tactile fever. Subjective SOB,  lump in throat, and hives on neck and face. Confusion. Lasted until the next day. Took Benadryl. Around midnight symptoms returned. Was scheduled to work Saturday, but was unable to do it. Symptoms were resolved by Sunday. Rash alsoresolved. Now 100% better.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY 10/30/17 AROUND 11 AM COMPLAINING OF LOCAL SITE PAIN SWELLING AND REDNESS AT THE VACCINATION SITE.
Age: 83.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Blister, Erythema, Pain in extremity, Skin warm
Clinical narrative: Recevied FLUAD and PREVNAR 13 vaccine to right arm on 10/10/17, history of mastectomy left breast.  C/o of pain and redness to right arm that began a few days after vaccination, and stated arm appeared to "have what looked like "blisters" on 10/17/18. Presented to clinic on 10/18/17 with large erythematous area and warmth noted to right arm, no "blisters" or open skin observed at that time.  Advised to follow up with PCP as soon as possible, was seen on 10/18/17 at urgent care. Patient reports healthcare provider at urgent care was unsure of "what was going on" and causing redness/warmth.  Was given prescription for oral steroid therapy.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, CSF protein increased, Dysstasia, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Patient received his flu vaccine on 9/8/2017. He went to the doctor on 10/5/2017 d/t 2-3 day history of progressive weakness to the point that the patient was unable to stand at his doctor's office.  His mentation/behavior was declining. Neurology was consulted and ordered MRIs. d/t the patient not being able to lay still they intubated him. An LP was done which showed increased protein suggestive of *AIDP (acute inflammatory demyelinating polyneuropathy). He was started on IVIG in the ICU, and began to show improvement rapidly. He was extubated 3 days later. He continued to work with PT/OT to improve over time. He was discharged on 10/16/2017 with home therapy.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Intensive care, Mental impairment, Nuclear magnetic resonance imaging
Clinical narrative: Patient received his flu vaccine on 9/8/2017. He went to the doctor on 10/5/2017 d/t 2-3 day history of progressive weakness to the point that the patient was unable to stand at his doctor's office.  His mentation/behavior was declining. Neurology was consulted and ordered MRIs. d/t the patient not being able to lay still they intubated him. An LP was done which showed increased protein suggestive of *AIDP (acute inflammatory demyelinating polyneuropathy). He was started on IVIG in the ICU, and began to show improvement rapidly. He was extubated 3 days later. He continued to work with PT/OT to improve over time. He was discharged on 10/16/2017 with home therapy.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: I had no initial reaction to the vaccine, but about 3 AM I woke with a throbbing ache from left shoulder to fingertips with numbness in my fingers of both hands that would not go away. I took some aspirin, fearing I might be having a heart attack. I sat up for a couple of hours trying to look up my symptoms on the internet and found that quite a few others had similar reactions to their vaccines. I went back to bed the pain continued. It subsided during the day, but then the next night I woke up again about 1AM with the same throbbing pain in my left arm, although less pronounced. I still have a slight ache/weakness in my left arm similar to getting hit in the funny bone.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: RASH ON LEFT ARM AND BACK ITCHING TAKING ZYRTEC SYMPTOMS LESS ON 10.30.2017.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Noticed diarrhea, nausea, abdominal pain a few hours after getting flu vaccine; had some low grade fever since then and consistent stomach pain, nausea, diarrhea x 5 days.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Bone pain, Chills, Erythema, Induration, Limb mass
Clinical narrative: Around 9pm 10/25 (~28hrs post vaccination PPSV23), developed rash on left arm, which started as patches but then consolidated to about a 4inch diameter, hot, hard area. Also developed bone pain (severe in left arm, moderate throughout), chills, fever (101.4 Tmax sustained), and throat swelling, with some respiratory distress. Self treated with Zyrtec 20mg x 1, Hydroxyzine 25mg x 1, and Albuterol 2 puffs q 15 minutes x3, Naproxen 440mg x1; throat swelling and respiratory distress resolved. On 10/26 am, rash still evolving; re-dosed Hydroxyzine 25mg x1. Sustained rash, bone pain, and fever for >48 hours (despite ATC Naproxen). As of today (10/30), still residual left arm bone pain and golf-ball size lump in arm with erythema.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pharyngeal oedema, Pyrexia, Rash, Respiratory distress, Skin warm
Clinical narrative: Around 9pm 10/25 (~28hrs post vaccination PPSV23), developed rash on left arm, which started as patches but then consolidated to about a 4inch diameter, hot, hard area. Also developed bone pain (severe in left arm, moderate throughout), chills, fever (101.4 Tmax sustained), and throat swelling, with some respiratory distress. Self treated with Zyrtec 20mg x 1, Hydroxyzine 25mg x 1, and Albuterol 2 puffs q 15 minutes x3, Naproxen 440mg x1; throat swelling and respiratory distress resolved. On 10/26 am, rash still evolving; re-dosed Hydroxyzine 25mg x1. Sustained rash, bone pain, and fever for >48 hours (despite ATC Naproxen). As of today (10/30), still residual left arm bone pain and golf-ball size lump in arm with erythema.
Age: 62.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Full blood count, Immediate post-injection reaction, Injection site joint movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Patient felt left arm pain immediately following the vaccination. Patient reports it became worse, causing restricted ROM and swelling at the site. Patient reports this increased over the last 3 weeks causing considerable pain to the left shoulder. Patient was seen in office and MRI of shoulder was ordered.
Age: 62.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient felt left arm pain immediately following the vaccination. Patient reports it became worse, causing restricted ROM and swelling at the site. Patient reports this increased over the last 3 weeks causing considerable pain to the left shoulder. Patient was seen in office and MRI of shoulder was ordered.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt came in the morning on 10/30/17 complaining of upper right arm soreness, said he got the flu shot in 10/11/17 and has been really sore and is unable to move his right arm above his head. Contacted his Primary care MD Dr 10:48am.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Hypersensitivity
Clinical narrative: The vaccine was for influenza, just not sure which specific type. 48 hours after receiving IM vaccine, the following symptoms started: Chills, fatigue, stomach pains, diarrhea, generalized aches all over body, allergy/sinus related issues. It is now 6 days after receiving the vaccine, and I am still sick. I believe this is viral, which is why I have not gone to a physician.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Sinus disorder
Clinical narrative: The vaccine was for influenza, just not sure which specific type. 48 hours after receiving IM vaccine, the following symptoms started: Chills, fatigue, stomach pains, diarrhea, generalized aches all over body, allergy/sinus related issues. It is now 6 days after receiving the vaccine, and I am still sick. I believe this is viral, which is why I have not gone to a physician.
Age: 5.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient's mother called on 10/24 stating red spots at injection site on right upper thigh, c/o pain when walking and fever. Patient came in on 10/26/17 with redness, swelling, warmth at injection site, otherwise feeling well.
Age: 5.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient's mother called on 10/24 stating red spots at injection site on right upper thigh, c/o pain when walking and fever. Patient came in on 10/26/17 with redness, swelling, warmth at injection site, otherwise feeling well.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Tearfulness
Clinical narrative: Patient states she felt a sharp pain radiating to her neck when receiving the vaccine. States it was the most painful vaccine she has ever received. She continued to have pain in her neck and shoulder to the point she was unable to move her arm to get her pajama top off. She arrived without an appointment to our office the next day complaining the pain was no better. During the exam, she was tearful when manipulating her arm or palpating around her neck and upper left arm. There was no swelling or erythema at the injection site. The site was appropriate as the punctum was visible. I consulted with our pediatric neurology department who stated the on-call neurologist was at the hospital, so it was recommended I refer her to our ED.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site rash
Clinical narrative: Redness, rash, and itchiness on vaccination site and surrounding area.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse prescriber (midwife) and refers to a 20-year-old female patient. The patient's medical history included pregnancy, delivery. The patient did not have any known drug reactions or allergies. On approximately 31-MAR-2017, the patient became pregnant with last menstrual period (LMP) estimated as 17-MAR-2017 and estimated date of delivery (EDD) of 22-DEC-2017. On the same day (31-MAR-2017), (also reported as "at her first postpartum visit"), the patient was vaccinated with VARIVAX lot # M034586 with an expiration date 27-JUL-2018, 0.5 ml, subcutaneously for routine the low prenatal titer for varicella (anatomical location was not reported). Other suspect therapies included sterile diluent (strength, dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant therapies included unspecified iron vitamins and prenatal vitamins. According to reporter, on 26-JUL-2017, the patient stated that she did not have her period. On 23-AUG-2017 the patient had anatomy ultrasound performed with normal results. On 06-OCT-2017, (also reported as "today"), the patient's state was described as: "good, stable condition for 29 weeks gestation'. No adverse effects were reported.  At the reporting time, the pregnancy outcome was outcome pending and fetus outcome was unknown.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of the following vaccines for prophylaxis: PROQUAD lot # N001490, expiration date (exp. date) 12-JUL-2018; M-M-R II lot # reported as "N048036", exp. date 08-DEC-2018,  or lot # M047302 exp. date 30-NOV-2018; VARIVAX lot # reported as "W001528" exp. date 13-JAN-2017, or lot # reported as "W002203" exp. date 19-JAN-2019; VAQTA lot # N014945, exp. date 31-AUG-2018, or lot # N005796, exp. date 26-MAY-2018; GARDASIL 9 lot # N017832, exp. date 16-NOV-2019, or lot # N014470, exp. date 17-JUN-2019; and ROTATEQ lot # N009948, exp. date 12-OCT-2018 orally (strength, route of administration, dose and dose # were not provided). The sterile diluent (MERCK) used for reconstitution of vaccines was properly stored. The vaccines were exposed to an unknown temperature excursion during a time frame of 72 hours which was detected by the data logger. There was no prior temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age (reported as older than 60 years of age). No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in approximately 2013, reported as 4 years ago, the patient was vaccinated with the first dose of ZOSTAVAX one dose (dose, route of administration, lot# and expiration date were not reported). On an unknown date, after vaccination the patient developed shingles. On 11-OCT-2017, the patient was vaccinated with the second dose of ZOSTAVAX. No adverse effects were reported after the second dose of ZOSTAVAX. The outcome of shingles was reported as recovered on an unknown date. No causality assessment was provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a consumer refers to her friend's child of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date in October 2017, the patient was vaccinated with an expired dose of ROTATEQ (orally; expiration date: 02-OCT-2017; dose and lot# were not provided).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 month old patient of unknown gender. The patient did not have pertinent medical history, drug reactions or allergies and was not taking concomitant medications. On 22-AUG-2017, the patient was vaccinated with the first dose of ROTATEQ orally, lot # N005617, expiry date: 03-OCT-2018 (dose not provided). The patient was 4 month old at a time of vaccination. On 28-SEP-2017, the patient was diagnosed with Rotavirus A after a positive stool culture. At a time of this report, the patient did not recover from gastroenteritis rotavirus, because was still having minor bouts of diarrhea. Outcome of positive stool culture was unknown. No treatment was given for the events. Causality assessment was not provided. Upon internal review, the event of gastroenteritis rotavirus was considered to be medically significant.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Skin warm
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable Pharmacist. A 69-year-old female patient received PREVNAR 13 (Lot # S51635, Expiry Date Oct2018, NDC # 00005197102) intramuscular at 0.5ml IM injection in left deltoid on 20Oct2017 for immunization, administered under protocol for pharmacy at Pharmacy/Drug store. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks included: influenza vaccine (FLU SHOT, Sanofi; Lot # UI867AC) IM at right arm administered the week before the suspect vaccination in Oct2017 for immunization. Additional vaccines administered on same date of the Pfizer suspect were none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient experienced arm was hot to touch on an unspecified date with outcome worsened, injections site was bright red and more than 7cm on an unspecified date with outcome worsened, soreness in left arm at injection site on 21Oct2017 with outcome of unknown (but patient still could work). The events did not require a visit to Emergency Room or Physician office. No relevant tests performed. The reporter considered injections site was more than 7cm a severe reaction. The reporter considered the events were related to PREVNAR 13. Amendment: This follow-up report is being submitted to amend previously reported information. The case is being assessed by Company Physician. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.