chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: Muscle aches; Chills; Pain at site; Redness; itching at insertion site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, chills, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the muscle pain, chills and injection site pain were recovered/resolved and the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, chills, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had muscle pain, chills and injection site pain after vaccination. The patient also had redness and itching at insertion site. The reporter asked what is the pathology that causes side effects with the second shot. The reporter did not consent to follow up. This case is 1 out of 3 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: Muscle Aches; Chills; Pain at site; Redness; itching at insertion site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, chills, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the muscle pain, chills and injection site pain were recovered/resolved and the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, chills, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 67 or 68 years. The reporter stated that the patient had muscle pain, chills and injection site pain after vaccination. The patient also had redness and itching at insertion site. The reporter asked what is the pathology that causes side effects with the second shot. The reporter did not consent to follow up. This case is 1 out of 3 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: Muscle Aches; Chills; Pain at site; Redness/ redness at insertion site; itching at the insertion site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, chills, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the muscle pain, chills and injection site pain were recovered/resolved and the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, chills, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 65 or 66 years old. The reporter stated that the patient had muscle pain, chills and injection site pain after vaccination. The patient also had redness and itching at insertion site. The reporter asked about the pathology that causes side effects with the second shot. The reporter did not consent to follow up. This case is 1 out of 3 cases reported by the same reporter
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia, Surgery
Clinical narrative: pneumonia; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the pneumonia was recovering/resolving.   It was unknown if the reporter considered the pneumonia to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's wife. The patient was hospitalized due to surgery and pneumonia. The patient was being seen by a home healthcare nurse.  Due to the unforeseen medical issues, the patient was unable to get the 2nd dose before the recommended 2 to 6 month period.  This case has been linked with case US2020018207 (wife's case), reported by same reporter.
Age: 0.5
Sex: M
Vaccine: TDAP, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 months old patient received Adacel instead of an age appropriate DTap vaccine, no AE; 6 months old patient received Adacel instead of an age appropriate DTap vaccine, no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 6 months male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of an age appropriate DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB).  On 31-Jan-2020, the patient received a 0.5 ml dose (DTP third dose) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5640AA and expiry date: 27-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination instead of an age appropriate DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  It was actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report, 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 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.
Age: 17.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: student missed a dose by one day, no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 year old male patient who has missed his dose by one day, while he received second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot R1C854M, Exp. Date 14-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to inappropriate schedule of product administration.   It was reported that the consumer missed their dose by one day even though she had emailed a reminder. States the consumer came in today for the second dose in the series and the series was being given prophylactically for travel.  At the time of reporting, no adverse reaction 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was unfortunately given an expired ActHIB vaccine, No Ae; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient who was vaccinated with expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] on an unknown date for prophylactic vaccination. The lot number: not reported and expiry date: 05-Dec-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  At the time of report 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 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.  Information on the batch number was requested.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone Quadrivalent MDV (opened) experienced a low temperature of 32.2F for 7 hours and 10 minutes, no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA030249, 2020SA030235, 2020SA030239, 2020SA030240, 2020SA030241, 2020SA030242, 2020SA030243, 2020SA030244, 2020SA030245, 2020SA030246, 2020SA030247 and 2020SA030248 (same reporter).  This case involves a 63 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ270AA, Exp. Date 30-Jun-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 24-Jan-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due product storage error temperature too low.   It was reported that Fluzone Quadrivalent MDV (opened) experienced a low of 32.2 F for 7 hours and 10 minutes related to a data logger malfunction-no human error and was opened on 09-Jan-2020.  At the time of report, 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 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.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Unevaluable event
Clinical narrative: Fluzone Quadrivalent MDV (opened) experienced a low temperature of 32.2F for 7 hours and 10 minutes, no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA030249, 2020SA030235, 2020SA030239, 2020SA030240, 2020SA030241, 2020SA030242, 2020SA030243, 2020SA030244, 2020SA030245, 2020SA030246, 2020SA030247 and 2020SA030248 (same reporter).  This case involves a 63 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ270AA, Exp. Date 30-Jun-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 24-Jan-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due product storage error temperature too low.   It was reported that Fluzone Quadrivalent MDV (opened) experienced a low of 32.2 F for 7 hours and 10 minutes related to a data logger malfunction-no human error and was opened on 09-Jan-2020.  At the time of report, 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 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.
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a nurse may have given an expired IPOL vaccine/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves female patient (of unknown demographics) who received an expired dose of IPV (VERO) [IPOL] (lot unknown, of Expiration date:14-Nov-2019) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  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.  Information on the batch number is requested.
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: a nurse administered TD (Tenivac) that expired on 25-Jan-2020 to a patient on 29-Jan-2020/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient of unknown age who was administered with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number not reported, expiration date: 25-Jan-2020) via unknown route at an unknown administration site for prophylactic vaccination on 29-Jan-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no adverse event.  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 and Module VI of the 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.  Information on the batch number is requested.
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired Daptacel on 31JAN2020/ no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 month old male patient who was vaccinated with an expired dose (0.5 mL, fourth dose in series) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5367AA, and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 31-Jan-2020.  Medical history, medical treatment, vaccination and family history were not provided.  It is a case of actual medication error due to expired vaccine used.   It was reported that patient was given the DAPTACEL vaccine, which was expired on 30-Jan-2020.  At the time of reporting, 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.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Ipol instead of Prolia injection/No AE; Initial information was received on 31-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 50 year old female patient who accidentally received IPV (VERO) [IPOL] instead of DENOSUMAB [PROLIA].  Medical history, medical treatment, vaccination and family history were not provided.   On 30-Jan-2020, the patient received a 0.5 ml first dose of suspect IPV (VERO) (lot P1F541M, Expiry date 07-Dec-2020) once via intramuscular route in the left deltoid in error.  It was a case of an actual medication error due to wrong product administered. Nurse stated that a 50 year-old patient came in for her Prolia injection, but the Medical Assistant administered Ipol. Consumer did receive Prolia afterward.  At the time of report, 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received pentacel which was excused at low temperature/no AE; patient received pentacel which was excused at low temperature/no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2020SA032086 and 2020SA032094 (same reporter).  This case involves a patient of unknown demographics who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ64BA, expiry date: 03-Feb-2021 via unknown route in unknown administration site) on 03-Feb-2020 which was excursed at low temperature and was not suitable for use (Poor quality product administered, Product storage error).  The patient medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error due to incorrect product storage (Product storage error) and Poor quality vaccine administered (Poor quality product administered).  It was reported that patient did not experience any adverse event.  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.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received Menactra wich was excursed at low temperature and was not suitable for use/no AE; patient received Menactra wich was excursed at low temperature and was not suitable for use/no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2020SA032086 and 2020SA032093 (same reporter).  This case involves a patient of unknown demographics who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6594AA, expiry date: 03-Feb-2021 via unknown route in unknown administration site) on 03-Feb-2020 which was excursed at low temperature and was not suitable for use (Poor quality product administered, Product storage error).  The patient medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error due to incorrect product storage (Product storage error) and Poor quality vaccine administered (Poor quality product administered).  It was reported that patient did not experience any adverse event.  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.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy skin, Pruritus, Rash erythematous, Skin test, Swelling
Clinical narrative: RED RASH WITH SWELLING ITCHING OVER 90% OF BODY. MOST PRONOUNCED ON FEET TO KNEES. IMMEDIATELY BEGAN DAY AFTER INJECTION.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Pt has had extreme shoulder pain, limited range of motion, can not do normal every day activities such as clasping bra strap, lifitng weights. has had to make modifications for daily activities. has seen a dr and taken ibuprofen 800mg, which did not alleviate pain and caused gi side effects. still in pain 1 month post immunization
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Erythema, Headache, Injection site urticaria, Nausea
Clinical narrative: Patient received 2nd dose of HPV (left arm) and Seasonal Influenza (right arm) at PE on 1/29/2020. On 1/31/2020, Mom and patient reported at the site of the flu vaccine patient had redness and swelling and itchy. Patient took a picture of her R arm at the site and had hives. Mom called our office on 02/04/2020, advised to gave Benadryl which she did and hives resolved.  Patient seen on 02/05/2020 in follow up due to headaches, nausea, itchiness and dizziness. At that visit, patient was still very itchy (whole body) but no more rash/hives.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Patient received 2nd dose of HPV (left arm) and Seasonal Influenza (right arm) at PE on 1/29/2020. On 1/31/2020, Mom and patient reported at the site of the flu vaccine patient had redness and swelling and itchy. Patient took a picture of her R arm at the site and had hives. Mom called our office on 02/04/2020, advised to gave Benadryl which she did and hives resolved.  Patient seen on 02/05/2020 in follow up due to headaches, nausea, itchiness and dizziness. At that visit, patient was still very itchy (whole body) but no more rash/hives.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: RIGHT deltoid cellulitis.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: PT was given TD instead of TDAP by accident.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Increasing pain in left arm (treated with Advil; ongoing as of 27 hours post-injection) Shivering, fever: onset ~14 hours post-injection, continued for ~4 hours Headache, mild nausea: onset ~20 hours post-injection, ongoing as of 27 hours post-injection
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Injection site joint pain, Injection site pain, Nausea
Clinical narrative: Localized muscle pain at injection site began to be joined by intense bone pain from mid-collar bone all the way down to mid palm.  Especially noticeable in shoulder joint, elbow joint, wrist joint.  Nausea with pain, but never threw up.  Tried massage by myself, then had my husband try all along the humerus avoiding injection site.  Zero relief. Even though I knew tylenol would suppress the immune response, I finally gave in at 10:15 pm that night and took two tylenol and two ibuprofen.  Relief came at about 11 pm that night.  Injection site still ached however.  Next day arm was painful to use while raising  it above elbow level, injection site still ached and continues still.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Localized muscle pain at injection site began to be joined by intense bone pain from mid-collar bone all the way down to mid palm.  Especially noticeable in shoulder joint, elbow joint, wrist joint.  Nausea with pain, but never threw up.  Tried massage by myself, then had my husband try all along the humerus avoiding injection site.  Zero relief. Even though I knew tylenol would suppress the immune response, I finally gave in at 10:15 pm that night and took two tylenol and two ibuprofen.  Relief came at about 11 pm that night.  Injection site still ached however.  Next day arm was painful to use while raising  it above elbow level, injection site still ached and continues still.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Body temperature increased, Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: 1-9-2020 4:30 pm: Nausea, dizzy, headache, face hot/extremities cold 1-10-2020 1 am Temp 100.7   Mom administered 50 mg Benadryl
Age: 21.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Peripheral coldness
Clinical narrative: 1-9-2020 4:30 pm: Nausea, dizzy, headache, face hot/extremities cold 1-10-2020 1 am Temp 100.7   Mom administered 50 mg Benadryl
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: - Muscle/body aches  fever, started on Monday, missed work on Tuesday due to sx - better by Thursday & Friday.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's parents and patient came to the Health Department 02/06/2020 approx. 4:30pm to talk to a nurse regarding the patient's injection site on her right arm. Patient's father stated Tuesday (02/04/2020) the patient cried throughout the night and he was unsure what was causing the crying and that he and his wife did not see the patient's arm until they gave the patient a bath on Thursday (02/06/2020), noticing the right arm was red and swollen, and brought her to the health department. This nurse and RN, noted the patient's right arm from the shoulder to the elbow had circumferential swelling, erythema, and warm to touch; branchial and radial pulse strong and capillary refill under 2 seconds. Raised erythema noted on right arm measuring 5 inches length with a girth of 3.5 inches. Patient's temperature was 98.7 tympanic and patient did not appear to be in distress. Patient's father denies any fever or respiratory distress since receiving the vaccine. Encouraged the patient's parents to take the child to her pediatrician or urgent care/ER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Impaired driving ability, Incomplete course of vaccination, Pain
Clinical narrative: Every joint in my body lit up with severe pain, including my spine. I was fine the day of the vaccination, but the following day in art class, I was sitting down and turned back to get a pencil to start drawing, and my entire spinal cord lit up in terrible pain, to the point that I screamed a little bit in shock and in pain. The entire day I was so fatigued in my shoulders, arms, hands and legs. It hurt to move to the point that I wanted to lay down, but I hung in there, not realizing or remembering that I had the Shingrix vaccine the day before. I went to drive home from my art college, but turning my head side to side was so painful. I had to manually move my head with my hand, and I drove very carefully home. I ran to the store on my way home to buy Tylenol XS, and I took 2 pills as I was standing in line at checkout. It was very painful, and I finally arrived home to hobble to my bed to rest. I fell asleep for 3 solid hours, I was in so much pain and my joints ached like something I never experienced in my life. I had to write to report this adverse reaction - I will NEVER consent to the second dosage of the Shingrix vaccination. The side effects were too harsh, too severe, too long - lasting. I had to deal with this arthritic type of pain for 2 full weeks before it calmed itself down. It felt like all of my joints were a rusted door on a boat. It was terrible.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Screaming, Spinal pain
Clinical narrative: Every joint in my body lit up with severe pain, including my spine. I was fine the day of the vaccination, but the following day in art class, I was sitting down and turned back to get a pencil to start drawing, and my entire spinal cord lit up in terrible pain, to the point that I screamed a little bit in shock and in pain. The entire day I was so fatigued in my shoulders, arms, hands and legs. It hurt to move to the point that I wanted to lay down, but I hung in there, not realizing or remembering that I had the Shingrix vaccine the day before. I went to drive home from my art college, but turning my head side to side was so painful. I had to manually move my head with my hand, and I drove very carefully home. I ran to the store on my way home to buy Tylenol XS, and I took 2 pills as I was standing in line at checkout. It was very painful, and I finally arrived home to hobble to my bed to rest. I fell asleep for 3 solid hours, I was in so much pain and my joints ached like something I never experienced in my life. I had to write to report this adverse reaction - I will NEVER consent to the second dosage of the Shingrix vaccination. The side effects were too harsh, too severe, too long - lasting. I had to deal with this arthritic type of pain for 2 full weeks before it calmed itself down. It felt like all of my joints were a rusted door on a boat. It was terrible.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received improperly stored vaccines; No adverse effects; This spontaneous report was received from a physician referring to a currently 19 years old female patient. The patient's pertinent medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccine dosage detail and route of administration were not reported; lot# R017630, expiration date: 18-DEC-2019) and with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccine dosage detail and route of administration were not reported; lot# R023503, expiration date: 16-AUG-2020, and lot# R009410, expiration date: 29-MAR-2020). Both vaccines were reconstituted with properly stored sterile diluent (STERILE DILUENT).  Administered doses of vaccines were exposed to a temperature excursion between -14 degrees Celsius to -10 degrees Celsius (-11 degrees Celsius) for 80 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  The case is linked to case# US-009507513-1905USA002947 due to the same patient. ; Sender's Comments:  US-009507513-1905USA002947:
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other adverse effects were reported in the patient.; a patient received one dose each of PROQUAD and MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 05-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccine dosage detail and route of administration were not reported; lot# S022914, expiration date 19-JAN-2021); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, vaccine dosage detail and route of administration were not reported; lot # S007813, expiration date 14-MAR-2021), both for prophylaxis (inappropriate schedule of product administration). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). No other adverse effects were reported in the patient. The outcome of inappropriate schedule of product administration was unknown.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Inappropriate schedule of product administration, Malaise
Clinical narrative: got her second dose past the six month on 01/21/2020; Chills; Sweats; feeeling sick / malaise all over her body; fatigue; below her breast, on the rib cage there is a feeling of prickling; below her breast, on the rib cage there is a feeling of itching; This case was reported by a consumer and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (For tolerance after 1st dose refer case US2019063128).   On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced chills, sweating, feeling unwell, fatigue, tingling and pruritus. On 21st January 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, sweating, feeling unwell, fatigue, tingling and pruritus were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills, sweating, feeling unwell, fatigue, tingling and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix vaccine and experienced chills, sweats, feeling sick, fatigue, and malaise all over her body. She also reported on the left side, below her breast, on the rib cage there was a feeling of prickling and itching. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient consents to followup with HCP
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Vaccine positive rechallenge
Clinical narrative: got her second dose past the six month on 01/21/2020; Chills; Sweats; feeeling sick / malaise all over her body; fatigue; below her breast, on the rib cage there is a feeling of prickling; below her breast, on the rib cage there is a feeling of itching; This case was reported by a consumer and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (For tolerance after 1st dose refer case US2019063128).   On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced chills, sweating, feeling unwell, fatigue, tingling and pruritus. On 21st January 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, sweating, feeling unwell, fatigue, tingling and pruritus were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills, sweating, feeling unwell, fatigue, tingling and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix vaccine and experienced chills, sweats, feeling sick, fatigue, and malaise all over her body. She also reported on the left side, below her breast, on the rib cage there was a feeling of prickling and itching. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient consents to followup with HCP
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 102 degrees; This case was reported by a consumer and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   The reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st Dose of Shingrix vaccine and experinced fever of 102 degrees F. The reporter did not consent to follow up. This case has been linked with US2020AMR018142, reported by same reporter.      Lab Comments: on an unknown date lab test was performed
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever of 102 degrees; This case was reported by a consumer and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance after 1st dose refer case US2020AMR018108.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was unknown.   The reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd Dose of Shingrix vaccine and experienced fever of 102 degrees F. The reporter did not consent to follow up. This case has been linked with US2020AMR018108, reported by same reporter.      Lab Comments: On an unknown date lab test was performed
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Burning sensation and hurt at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site burning in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown.   It was unknown if the reporter considered the injection site burning to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported that more than one patient experienced burning sensation and hurt at injection site, after receiving 1st dose of Fluarix Quadrivalent. No other information was reported. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Chest pain, Herpes zoster, Rash
Clinical narrative: shingles; chest pain; rash over her left breast; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd September 2019).   On 6th January 2020, the patient received the 2nd dose of Shingrix, Influenza vaccine and the 2nd dose of PNEUMONIA VACCINE (intramuscular). On 14th January 2020, 8 days after receiving Shingrix, Influenza vaccine and PNEUMONIA VACCINE, the patient experienced shingles and chest pain. In January 2020, the patient experienced rash. On an unknown date, the outcome of the shingles, chest pain and rash were unknown.   It was unknown if the reporter considered the shingles, chest pain and rash to be related to Shingrix and Influenza vaccine.  Additional details were reported as follows: The patient received 2nd dose of Shingrix vaccine and experienced chest pain and rash over her left breast. She visited her physician and was diagnosed with shingles. No other information was reported. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Pain in extremity, Rash
Clinical narrative: shingles; chest pain; rash over her left breast; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd September 2019).   On 6th January 2020, the patient received the 2nd dose of Shingrix, Influenza vaccine and the 2nd dose of PNEUMONIA VACCINE (intramuscular). On 14th January 2020, 8 days after receiving Shingrix, Influenza vaccine and PNEUMONIA VACCINE, the patient experienced shingles and chest pain. In January 2020, the patient experienced rash. On an unknown date, the outcome of the shingles, chest pain and rash were unknown.   It was unknown if the reporter considered the shingles, chest pain and rash to be related to Shingrix and Influenza vaccine.  Additional details were reported as follows: The patient received 2nd dose of Shingrix vaccine and experienced chest pain and rash over her left breast. She visited her physician and was diagnosed with shingles. No other information was reported. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: shingles; chest pain; rash over her left breast; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd September 2019).   On 6th January 2020, the patient received the 2nd dose of Shingrix, Influenza vaccine and the 2nd dose of PNEUMONIA VACCINE (intramuscular). On 14th January 2020, 8 days after receiving Shingrix, Influenza vaccine and PNEUMONIA VACCINE, the patient experienced shingles and chest pain. In January 2020, the patient experienced rash. On an unknown date, the outcome of the shingles, chest pain and rash were unknown.   It was unknown if the reporter considered the shingles, chest pain and rash to be related to Shingrix and Influenza vaccine.  Additional details were reported as follows: The patient received 2nd dose of Shingrix vaccine and experienced chest pain and rash over her left breast. She visited her physician and was diagnosed with shingles. No other information was reported. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Achy like someone  stepped on her; Redness at the injection site; Swelling at the injection site; Intense itching where the swelling is; Muscles felt achy; Heat/ felt feverish; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced pain, injection site erythema, injection site swelling, injection site itching, myalgia and feeling hot. The patient was treated with PARACETAMOL (TYLENOL). On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the injection site itching was resolved with sequelae and the outcome of the myalgia and feeling hot were unknown.   It was unknown if the reporter considered the pain, injection site erythema, injection site swelling, injection site itching, myalgia and feeling hot to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and felt feverish and achy like someone stepped on her. She had redness and swelling at the injection site, which she treated with a warm soaks. She also stated that she had intense itching where the swelling was on her arm. The itching was resolved but the redness and swelling were still there although they were improved. The patient still felt like someone stepped on her at time of reporting and took Tylenol to relieve the symptoms. She also stated that her muscles felt achy. The reporter consented to follow up.