chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2010, the patient was inoculated with ZOSTAVAX at a physician's office for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. On or about 29-AUG-2016, the patient was treated by a physician at an urgent care for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 8-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccines experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This is one of several reports with the same reporter.
Sex: F
Vaccine: FLUX, PNC13, PPV
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer-sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration in separate arms on an unspecified date at single dose for immunization; PNEUMOVAX and influenza vaccine (FLU), via an unspecified route of administration in separate arms on an unspecified date date at an unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced heart rate went up to about 130 and difficulty breathing on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPV, HIBV, MMRV, TDAP
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old female patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number U5979AA and Exp. date 13-Jun-2020) via intramuscular route in the left thigh on 05-Sep-2018. On 05-Sep-2018, the patient also received a dose of suspect INFANRIX lot number not reported via unknown route in unknown administration site. The patient's medical history was not reported. Concomitant medications included KINRIX for Immunization; PROQUAD for Immunization; and HIBERIX for Immunization. It was an actual medication error due to extra dose administered as patient was given ADACEL as well as INFANRIX at same time in error and both are Tetanus, Diphtheria, and acellular pertussis vaccines. No adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 72 years old male patient who received vaccine FLUZONE HIGH DOSE 0.5ml dose, lot UI885AA, expiry date 29-May-2018 via unknown route in unknown administration site on 10-Sep-2018. The patient's past medical history, concomitant medication and family history were not provided. No other vaccines given at the time. It was an actual medication error due to expired vaccine used. It was reported that patient received FLUZONE HIGH DOSE from 2017-2018 season on 10-Sep-2018 that had expired on 29-May-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLUR4, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from an Non-Health Professional. This case is linked to case 2018SA261690 (same reporter). This case involves an 11 years old patient he/she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunization. On 23-Aug-2018, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot 2FAA1802 via unknown route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccination as 11 year old patient received FLUBLOK QIV. It was not reported if any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a physician (Pediatrician). This case involves an unknown demographic patient who was vaccinated with a dose of ACT-HIB (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to patient was administered ACTHIB without the DTaP-IPV diluent (product preparation error). No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional (pharmacy other). This case involves a two-months old patient who received only DAPTACEL (DTAP component) and IPOL (IPV component) was mixed with the sterile water and not the ACTHIB (HIB component) of PENTACEL lot number not reported on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that DAPTACEL and IPOL were mixed with Sterile Water. Also stated that he might have that mixed up and it might have been the ACTHIB mixed with Sterile water and not the DAPTACEL and IPOL. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Product preparation issue
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four-months old male patient who experienced crying for a minute, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; HEPATITIS B VACCINE for Immunisation; ROTATEQ for Immunisation; and ENERGIX. On 13-Sep-2018, the patient received a 0.5 mL second dose of suspect DTAP IPV Lot: C5409AA and HIB Lot: C5552AA, expiry date: 10-Oct-2019) via intramuscular route in the left thigh. On an unknown date, the patient developed a non-serious crying for a minute (crying), following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was also a case of actual medication error due to inappropriate reconstitution technique. The patient was administered PENTACEL but due to an error in reconstitution they did not get the HIB part of the vaccine. It was also reported that nurse then reconstituted the HIB portion with the 0.4 percent NaCl saline solution as directed and gave the patient the HIB portion of the PENTACEL injection. All parts of the PENTACEL injection were given on the same day. Relevant tests were not reported. Final diagnosis was crying for a minute. It was not reported if the patient received a corrective treatment. On an unknown date, the patient was recovered from the event (duration reported as a minute). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Age: 0.25
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three-months-old male patient who received a 0.5 ml first dose of PENTACEL lot C551CAA via intramuscular route in the right thigh and 0.5 ml first dose of DAPTACEL lot C5254AA via intramuscular route in the left thigh on 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; HEPATITIS B VACCINE for Immunisation; and PNEUMOCOCCAL VACCINE for Immunisation. It was a case of actual medication error due to extra dose administered as the patient received PENTACEL and DAPTACEL on the same day. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse via phone on 14-SEP-2018. This case involves a 3 year 8 months male child who was vaccinated with 0.5 ml (25 gauge needle 1 inch in size) expired dose of PENTACEL (batch number C5421AA, expiry date 02 Sep 2018, intramuscularly in left thigh (Left vastus laterus) and diluent (lot number C5230AA, expiry date 02 Sep 2018) on an unspecified date. It was a case of actual medication error as expired vaccine used. It was reported patient did not go to Emergency room. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 months old male patient who received vaccines PENTACEL and DAPTACEL on 13 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine; Hepatitis B Vaccine for Immunisation; and Pneumococcal Vaccine for Immunisation. On 13-Sep-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, lot C551CAA via intramuscular route in the right thigh. On 13-Sep-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, lot C5254AA via intramuscular route in the left thigh. It was a case of actual medication error due to extra dose administered. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Headache, very sore arm, fever, fatigue, muscle aches.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood 25-hydroxycholecalciferol, Blood folate, Differential white blood cell count, Fatigue, Full blood count
Clinical narrative: Detailed inspection - Visual lesions: wheal(s), Color: red, Shape: round, Size: 6cm, Arrangement: isolated, Distribution: localized, Side: right, Location: deltoid, Status: stable. Skin comments right deltoid SHINGRIX injection site-2 days ago. Assessment-Fatigue, unspecified type (R53.83). Patient Plan Take daily multivitamin. Will check lab today. Call on Monday for results. Rest this weekend. Symptoms are likely from the SHINGRIX vaccine. Provider Plan Patient received SHINGRIX vaccine 3 days ago and is having local reaction at site of injection. Patient also with fatigue and headache, these are listed as possible reactions to the vaccine and are likely just a reaction, however patient has a Hx of vitamin deficiency and anemia. Will check lab values. Advised to take daily MVI. Plan Orders CBC with Diff to be performed Today, Vitamin B12 and Folate to be performed Today and Vitamin D, 25-Hydroxy to be performed Today. Assessment Adverse effect of vaccine, initial encounter (T50.Z95A). Patient Plan Rest this weekend MOTRIN as needed for the pain. Provider Plan Patient had SHINGRIX vaccine on 9-19-2018. Developed indurated area approximately 6cm, painful and warm. Patient also with fatigue and headache. VAERS form completed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria
Clinical narrative: Detailed inspection - Visual lesions: wheal(s), Color: red, Shape: round, Size: 6cm, Arrangement: isolated, Distribution: localized, Side: right, Location: deltoid, Status: stable. Skin comments right deltoid SHINGRIX injection site-2 days ago. Assessment-Fatigue, unspecified type (R53.83). Patient Plan Take daily multivitamin. Will check lab today. Call on Monday for results. Rest this weekend. Symptoms are likely from the SHINGRIX vaccine. Provider Plan Patient received SHINGRIX vaccine 3 days ago and is having local reaction at site of injection. Patient also with fatigue and headache, these are listed as possible reactions to the vaccine and are likely just a reaction, however patient has a Hx of vitamin deficiency and anemia. Will check lab values. Advised to take daily MVI. Plan Orders CBC with Diff to be performed Today, Vitamin B12 and Folate to be performed Today and Vitamin D, 25-Hydroxy to be performed Today. Assessment Adverse effect of vaccine, initial encounter (T50.Z95A). Patient Plan Rest this weekend MOTRIN as needed for the pain. Provider Plan Patient had SHINGRIX vaccine on 9-19-2018. Developed indurated area approximately 6cm, painful and warm. Patient also with fatigue and headache. VAERS form completed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Vitamin B12, Vitamin D
Clinical narrative: Detailed inspection - Visual lesions: wheal(s), Color: red, Shape: round, Size: 6cm, Arrangement: isolated, Distribution: localized, Side: right, Location: deltoid, Status: stable. Skin comments right deltoid SHINGRIX injection site-2 days ago. Assessment-Fatigue, unspecified type (R53.83). Patient Plan Take daily multivitamin. Will check lab today. Call on Monday for results. Rest this weekend. Symptoms are likely from the SHINGRIX vaccine. Provider Plan Patient received SHINGRIX vaccine 3 days ago and is having local reaction at site of injection. Patient also with fatigue and headache, these are listed as possible reactions to the vaccine and are likely just a reaction, however patient has a Hx of vitamin deficiency and anemia. Will check lab values. Advised to take daily MVI. Plan Orders CBC with Diff to be performed Today, Vitamin B12 and Folate to be performed Today and Vitamin D, 25-Hydroxy to be performed Today. Assessment Adverse effect of vaccine, initial encounter (T50.Z95A). Patient Plan Rest this weekend MOTRIN as needed for the pain. Provider Plan Patient had SHINGRIX vaccine on 9-19-2018. Developed indurated area approximately 6cm, painful and warm. Patient also with fatigue and headache. VAERS form completed.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Paraesthesia, Vascular pain
Clinical narrative: Very sensitive area on the right arm (like needles poking the skin). Painful when touching vein in right wrist.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Vaccine Clinic Coordinator received a phone call from patient's mother reporting that her child's left arm where the KINRIX shot was given on 9/18/18 was swollen, tender, red and warm to touch. Itching was also noted. Mother was instructed to apply ice to site and give age appropriate dose of ibuprofen. Notified patient's family physician, to inform her of the above report. NP did not have any further orders. Called patient's mother back to let her know that I had contacted her family physician. Instructed her to take patient to Urgent Care if the swollen site became enlarged, hard or child developed a fever. Spoke with the patient's mother on 9/21/18 early in the day to check on patient. She reports that the injection site had spread and patient developed a "hard lump" which became hot to the touch. Urgent Care prescribed Amoxicillin TID X 10 days. Family gave her a dose of BENADRYL also. She was instructed to bring her back in today if the lump didn't start to subside.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Vaccine Clinic Coordinator received a phone call from patient's mother reporting that her child's left arm where the KINRIX shot was given on 9/18/18 was swollen, tender, red and warm to touch. Itching was also noted. Mother was instructed to apply ice to site and give age appropriate dose of ibuprofen. Notified patient's family physician, to inform her of the above report. NP did not have any further orders. Called patient's mother back to let her know that I had contacted her family physician. Instructed her to take patient to Urgent Care if the swollen site became enlarged, hard or child developed a fever. Spoke with the patient's mother on 9/21/18 early in the day to check on patient. She reports that the injection site had spread and patient developed a "hard lump" which became hot to the touch. Urgent Care prescribed Amoxicillin TID X 10 days. Family gave her a dose of BENADRYL also. She was instructed to bring her back in today if the lump didn't start to subside.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Patient reported fever for 3 days, arm very sore (sensitive to air blowing over area) and hard lump at site of injection. After 7 days an approximately 2.5 inch circular area is still red and there is a painful lump at injection site.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Patient reported fever for 3 days, arm very sore (sensitive to air blowing over area) and hard lump at site of injection. After 7 days an approximately 2.5 inch circular area is still red and there is a painful lump at injection site.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Infection, Injection site swelling
Clinical narrative: Pt began having swelling of the right thigh at the injection site the day after receiving the vaccine.  Redness continued to worsen and the patient was seen in the office yesterday. Diagnoses with either a hypersensitive reaction or an infection. Told to start childrens Claritin and if not better today to start the Keflex today.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: 2 hours after the vaccine arm was stiff and very painful, got worst through out the evening. Could hardly move arm all night and into the next day. By the next day 9/20/18 was still very painful and by 7pm that evening the site was red, raised, and hot to the touch. Redness and swelling the side of a dollar bill. Today 9/21/18 still swollen and red and sore.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: 2 hours after the vaccine arm was stiff and very painful, got worst through out the evening. Could hardly move arm all night and into the next day. By the next day 9/20/18 was still very painful and by 7pm that evening the site was red, raised, and hot to the touch. Redness and swelling the side of a dollar bill. Today 9/21/18 still swollen and red and sore.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: PAIN IN LEFT ARM RADIATING TO BACK.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Erythema of eyelid, Eyelid pain, Injection site erythema, Pruritus
Clinical narrative: Patient reported a progession of red and painful/itchy eruptions since the vaccination. The following morning around 24 hours after injection she had redness on her right eyelid and a half dollar sized area 3 inches below injection site. On Monday morning she developed redness in an area on her lower abdomen, On Tuesday her left eyelid became red and painful as well as widespread itching of her face and head. She also developed a red "blotch" on her neck. Patient was directed to consult regular provider. The doctor had her start taking loratadine 10 mg daily which did help the symptoms decrease - the itching resolved and the redness lightened, but did not fully go away. Patient reports that she cannot think of anything else that changed in her routine. Patient reported no allergic symptoms at the time of injection and medical provider could not find any specific condition causing the symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Patient reported a progession of red and painful/itchy eruptions since the vaccination. The following morning around 24 hours after injection she had redness on her right eyelid and a half dollar sized area 3 inches below injection site. On Monday morning she developed redness in an area on her lower abdomen, On Tuesday her left eyelid became red and painful as well as widespread itching of her face and head. She also developed a red "blotch" on her neck. Patient was directed to consult regular provider. The doctor had her start taking loratadine 10 mg daily which did help the symptoms decrease - the itching resolved and the redness lightened, but did not fully go away. Patient reports that she cannot think of anything else that changed in her routine. Patient reported no allergic symptoms at the time of injection and medical provider could not find any specific condition causing the symptoms.
Age: 51.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Body temperature increased, Erythema, Feeling abnormal, Impaired work ability, Pain in extremity
Clinical narrative: Patient was given the vaccine about 8:00am on Tuesday, September 18, 2018. Patient states they started feeling bad and arm started hurting about 1:20PM.  They called the pharmacy and pharmacist on duty instructed them to take benadryl,  ibuprofen or tylenol, and to contact their physician if it did not get better. Patient took 2 benadryl tablets after getting home from work after 4pm. States arm had 2 x 3 cm red "bump" and was very warm to the touch. Patient states they also had a temperature of 100.2  The next day, arm still hurt and was red. They attempted to go to work and stayed 1/2 day.  She took two more bendadrl  tablets that evening and ibuprofen and put a cold pack on it, but stated it still hurt. After pharmacist and patient consultation, patient was advised to see physician. Patient is going to see physician on Friday, 9.21.2018.
Age: 51.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient was given the vaccine about 8:00am on Tuesday, September 18, 2018. Patient states they started feeling bad and arm started hurting about 1:20PM.  They called the pharmacy and pharmacist on duty instructed them to take benadryl,  ibuprofen or tylenol, and to contact their physician if it did not get better. Patient took 2 benadryl tablets after getting home from work after 4pm. States arm had 2 x 3 cm red "bump" and was very warm to the touch. Patient states they also had a temperature of 100.2  The next day, arm still hurt and was red. They attempted to go to work and stayed 1/2 day.  She took two more bendadrl  tablets that evening and ibuprofen and put a cold pack on it, but stated it still hurt. After pharmacist and patient consultation, patient was advised to see physician. Patient is going to see physician on Friday, 9.21.2018.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Diarrhoea, Malaise, Nausea
Clinical narrative: Within 1 hour of receiving her first ever flu vaccine she became ill. -forceful vomiting, nausea, chills , sleepiness -last approx 20-24 hours -residual nausea & lack of appetite -reporting diarrhea but it is unclear if this is related to other Sx as she was reporting diarrhea on the day of her vaccination.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence, Vomiting
Clinical narrative: Within 1 hour of receiving her first ever flu vaccine she became ill. -forceful vomiting, nausea, chills , sleepiness -last approx 20-24 hours -residual nausea & lack of appetite -reporting diarrhea but it is unclear if this is related to other Sx as she was reporting diarrhea on the day of her vaccination.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Constant pain in deltoid muscle and possibly in joint. Pain increases with extension, which renders certain movements impossible. It seems to be getting worse over time.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Patient received flu shot on 9/11 and experienced nerve pain after injection.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Burning sensation, Pain
Clinical narrative: PATIENT STATED HE HAD BURNING THROUGHOUT THE BODY AND PAIN.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: Pt complain of temp 102.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pruritus, Injection site warmth, Pruritus, Skin warm
Clinical narrative: Itching and warmth in upper left arm, chest and chin.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient experienced swelling and redness and warmth in approximately half of the upper arm. Also experienced soreness, but not more than expected amount.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe pain, swelling, redness and fever at location, joint pain, fever from time of injection. Joint pain is better now, fever is gone, but location is still extremely painful, swollen, and hot to touch.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe pain, swelling, redness and fever at location, joint pain, fever from time of injection. Joint pain is better now, fever is gone, but location is still extremely painful, swollen, and hot to touch.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest discomfort, Condition aggravated
Clinical narrative: Pt had existing chest tightness before the vaccine, but wife stated that it was extreme after the shot for the weekend (vaccine was admin on Friday). He went to cardiologist Monday and his BP was 190/86, when he is normally in the 130s.
Age: 60.0
Sex: U
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid - erythema/increased, warm to touch, mild tenderness. Tx: cold/ice pack/BENADRYL/OTC NSAIDs.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient returned with a red, warm rash on the left arm near injection site that extended 5 inches downward towards the elbow. No itching or pain, no sores.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Rash, Rash erythematous
Clinical narrative: Red fine rash appeared on face immediately after shot was given and fine rash appeared on thigh approx. three minutes after shot was given. On 09/19/2018 contact client fifteen minutes after she left the Health Center, client was driving and I ask how are you feeling?, Client replied "I feel fine." Also contact client one hour and thirty minutes later, and I ask had she seek medical attention and she replied "no"! Recommended to seek medical attention to have blood work drawn to see if she is allergy to any of the component in the vaccine.
Age: 70.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Abdominal pain lower, Back pain, Gait inability, Groin pain
Clinical narrative: Sudden onset of lower abdomianl, back, groin pain such that she was unable to walk. Symptoms resolved over 30-40 minutes with 600 mg ibuprofen. No sequelae noted.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Headache, Fever and Chills, muscle aches, sweating.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Received vaccine 09/10/2018 started with fever on 9/18/18 then rash, red bumps on 9/20/18. Received ZOVIRAX medication prescription in office 9/18/18. Patient recovering.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: Received vaccine 09/10/2018 started with fever on 9/18/18 then rash, red bumps on 9/20/18. Received ZOVIRAX medication prescription in office 9/18/18. Patient recovering.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Immune system disorder, Malignant melanoma, Melanocytic naevus, Pruritus
Clinical narrative: After getting my SHINGRIX shot, the keloid on my shoulder began to itch a great deal. Also, a tiny mole on my calf began to itch just as much. With both spots bothering me (itching quite a bit throughout the day as well as nighttime) I went to the dermatologist. She took a biopsy of the mole and it was found to be malignant melanoma. I subsequently had to have surgery to remove the Stage 1 melanoma mole and corresponding lymph node. My oncologist says the SHINGRIX vaccine caused my body to crank up my immune system and in doing so, the immune system was attacking the melanoma growth. This is the activity that caused the itch. I'm lucky. My immune system could not win against the melanoma, but it caused a reaction that got me to make an appointment with my dermatologist, which caused me to catch the growth in a very early phase.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin neoplasm excision
Clinical narrative: After getting my SHINGRIX shot, the keloid on my shoulder began to itch a great deal. Also, a tiny mole on my calf began to itch just as much. With both spots bothering me (itching quite a bit throughout the day as well as nighttime) I went to the dermatologist. She took a biopsy of the mole and it was found to be malignant melanoma. I subsequently had to have surgery to remove the Stage 1 melanoma mole and corresponding lymph node. My oncologist says the SHINGRIX vaccine caused my body to crank up my immune system and in doing so, the immune system was attacking the melanoma growth. This is the activity that caused the itch. I'm lucky. My immune system could not win against the melanoma, but it caused a reaction that got me to make an appointment with my dermatologist, which caused me to catch the growth in a very early phase.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Bruxism, Drooling, Dyspnoea, Tremor, Vomiting
Clinical narrative: On 9-20-2018 patient received flu vaccine while in clinic. On 9-21-18 at 1:30am patient was awake and asked for some milk, then she started drooling, vomited and had started drooling again, her jaw was clenched and lower legs shaking and difficulty breathing. Mother took her to hospital e.r and arrived at 2:39am on 9-21-2018, discahrged at 3:34am and was doing well at that time. she was smiling and playful at the time of discharge. Patient had an appointment today 9-21-2018 to see Dr, pediatrician.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red and slightly raised. Warm to the touch and covering an area from above the elbow to the upper arm. Improving per the patient.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient received vaccine on 9/11/2018. Came in to the office on 9/20/2018 with fever, rash. Parent gave Ibuprofen prior to coming into office. No other prescriptions given.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient received vaccine on 9/11/2018. Came in to the office on 9/20/2018 with fever, rash. Parent gave Ibuprofen prior to coming into office. No other prescriptions given.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Neck pain
Clinical narrative: Pain radiating up the neck into the scalp and down the jar on right side after flu shot. Patient was examined and it was determined that she is suffering from a migraine headache. Medications were prescribed and a referral to a neurologist was recommended.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Alcohol test, Angiogram, Computerised tomogram head, Drug screen, Electrocardiogram
Clinical narrative: Patient was given injection at the clinic, watched for 15 minutes with no adverse reaction noted, patient went home and several hours later called EMS for numbness/weakness to left side.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Hemiparesis, Hypoaesthesia, Myocardial necrosis marker
Clinical narrative: Patient was given injection at the clinic, watched for 15 minutes with no adverse reaction noted, patient went home and several hours later called EMS for numbness/weakness to left side.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Patient presented to primary care physician with irritation to left deltoid and erythema presenting from deltoid to an area 3-4 inches above the elbow. Area is warm to the touch. Treatment- Patient prescribed KEFLEX by prescriber to be started today (09/21). Patient told to apply cool compresses and to take some BENADRYL. Outcome - Visited PCP. Final resolution of symptoms to be determined, will follow up with patient in 24 - to 48 hours, clinical effects expected to be minimal and are expected to resolve promptly.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Pain in extremity
Clinical narrative: Influenza given the evening of 9/19/18 in the left deltoid. He woke up on 9/20/18 c/o pain in his arm. By early afternnon, his entire upper arm was swollen, red and painful. He was diagnosed with a local reaction to the flu vaccine and advised to apply ice and gice BENADRYL every 8 hours.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported severe hives and itching all over her body. She went to urgent care and saw nurse practitioner and received Triamcinolone 0.05% cream, MEDROL DOSEPAK, and CALADRYL 1%-8% for treatment. Pharmacist contacted patients PCP and informed them about the adverse reaction and the MA stated she would make a follow up appointment with the patient. Pharmacist attempted to call to follow up with patient on 9/21/18 and left message. Will continue to check in with the patient.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Patient reported severe hives and itching all over her body. She went to urgent care and saw nurse practitioner and received Triamcinolone 0.05% cream, MEDROL DOSEPAK, and CALADRYL 1%-8% for treatment. Pharmacist contacted patients PCP and informed them about the adverse reaction and the MA stated she would make a follow up appointment with the patient. Pharmacist attempted to call to follow up with patient on 9/21/18 and left message. Will continue to check in with the patient.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Influenza like illness, Injection site erythema
Clinical narrative: Immediate pain in upper arm...most painful vaccine I ever received. Had pain, redness, and soreness at injection site that later radiated through my arm and down the interior side of my arm through the muscle to my elbow. Also had significant fatigue, headache, felt like I had a fever and flu like symptoms for two days afterwards. The should pain has persisted.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia, X-ray limb
Clinical narrative: Immediate pain in upper arm...most painful vaccine I ever received. Had pain, redness, and soreness at injection site that later radiated through my arm and down the interior side of my arm through the muscle to my elbow. Also had significant fatigue, headache, felt like I had a fever and flu like symptoms for two days afterwards. The should pain has persisted.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cough, Discomfort, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Patient called at about 7pm to report she feels sick. She had received FLUZONE and SHINGRIX shots on 09/13/18. Her symptoms started on the night of 9/17/18 and includes achy feeling, cough and sore throat. She said that she feels "death warmed over". She was asked to contact her Doctor and she said she had an appointment on October 8, 2018. She was advised to contact her Doctor again and see if she can be seen sooner. However, if it was not possible, to go to a Hospital Emergency department so that her condition can be properly evaluated. She acknowledged she has a husband who can take her to ER if it gets worse. In the meantime, she will try to rest and use her inhaler and if it is not sufficient, she will use her nebulizer treatment. She also has a history of COPD, chronic Asthma and Bronchitis. She admits that she had no TYLENOL and have taken Ibuprofen and Naproxen alternatingly to relive her discomfort. Pharmacist advised her to go to the ER to be properly to be evaluated. She was thankful for the Pharmacist's concern and time. Patient also take Morphine and Oxycodone for severe pain.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dry throat, Dyspnoea, Headache, Oropharyngeal pain, Paraesthesia
Clinical narrative: Approx 10 minutes after vaccine administration, patient reported headache, sore throat, tingling in arms, difficulty breathing, and dry throat. At 10:45 am administered 0.3ml of EPI to left thigh. At 10:50 am patient reported less tingling in hands/arms, started feeling better. At 11:15am resting comfortably, no distress noted.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Hot to the touch and has inflammation and redness.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-AUG-2018, the patient was vaccinated with an improperly stored M-M-R II lot # N023146, expiration date: 24-AUG-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with an improperly stored sterile diluent (manufacturer unknown) lot# N030026 (also reported as #030026), expiration date: 04-JUN-2020. The vaccine and sterile diluent were exposed to temperature in the range of 9 degrees Celsius to 25 degrees Celsius for 13 days. Temperature excursion was not detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1809USA001804: US-009507513-1809USA001805.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were not reported. On 20-AUG-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N023146, expiration date: 24-AUG-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with an improperly stored sterile diluent (manufacturer unknown) lot# N030026 (also reported as #030026), expiration date: 04-JUN-2020. The vaccine and sterile diluent were exposed to temperature in the range of 9 Celsius degrees to 25 Celsius degrees for 13 days. Temperature excursion was not detected by a data logger. There was no previous temperature excursion. No adverse events were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1808USA011459: US-009507513-1809USA001805.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 23-OCT-2012, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 10-SEP-2015, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.